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A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03

Primary Purpose

Gastroparesis, Diabetes Mellitus

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Relamorelin
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis focused on measuring diabetic gastroparesis, vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants are eligible to be included in the study only if all the following criteria apply:
  • Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study
  • Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures
  • In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02

Exclusion Criteria:

  • Participants are excluded from the study if any of the following criteria apply:
  • Participant is not willing or able to abide by the restrictions regarding concomitant medicine use
  • Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03
  • Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study
  • Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease

Sites / Locations

  • North Alabama Research Center, LLC
  • Digestive Health Specialist of the South East
  • G & L Research, LLC
  • Alabama Medical Group, PC
  • Del Sol Research Management, LLC
  • Phoenix Clinical LLC.
  • Del Sol Research Management, LLC
  • Preferred Research Partners, Inc.
  • Applied Research Center of Arkansas
  • Arkansas Gastroenterology
  • Unity Health - Searcy Medical Center
  • Hope Clinical Research
  • GW Research Inc
  • Kindred Medical Institute for Clinical Trials, LLC
  • Aurora Care Clinic, LLC
  • Diagnamics Inc.
  • VVCRD Research
  • University of California San Diego
  • Om Research LLC
  • Torrance Clinical Research Institute, Inc.
  • Angel City Research Inc.
  • TriWest Research Associates
  • Medical Associates Research Group, Inc
  • Syrentis Clinical Research
  • Upland Clinical Research
  • Peak Gastroenterology Associates
  • Synexus Clinical Research US, Inc. - Colorado Springs Family Practice
  • Gastroenterology Associates of Fairfield County, P.C.
  • TrialSpark, Inc.
  • Innovative Research of West FL, Inc.
  • West Central Gastroenterology
  • Clinical Research of West Florida
  • ALL Medical Research LLC
  • Top Medical Research
  • Palmetto Research, LLC
  • Vida Clinical Trials
  • Nature Coast Clinical Research
  • Panax Clinical Research, LLC.
  • Savin Medical Group LLC
  • APF Research LLC
  • AMPM Research Clinic
  • Advanced Medical Research Institute
  • Florida Research Center, Inc.
  • American Research Institute, Inc
  • Synexus
  • Atlanta Diabetes Associates
  • Emory University
  • River Birch Research Alliance, LLC
  • Gwinnett Research Institute, LLC
  • Summit Clinical Research, LLC.
  • iResearch Atlanta LLC
  • Infinite Clinical Trials
  • Clinical Research Consultants of Atlanta
  • Rocky Mountain Diabetes and Osteoporosis Center, PA
  • Southwest Gastroenterology
  • MediSphere Medical Research Center, LLC
  • American Research, LLC
  • University of Iowa Hospitals and Clinics
  • University of Kansas Medical Center
  • Health Science Research Center
  • WestGlen Gastrointestinal Consultants
  • Cotton-O'Neil Clinical Research Center - Digestive Health
  • Kansas Medical Clinic
  • Professional Research Network of Kansas, LLC
  • Via Christi Clinic, PA
  • Tri-State Gastroenterology
  • University of Louisville
  • Delta Research Partners
  • WK Physicians Network
  • Avant Research Associates LLC
  • Cronola LLC
  • Clinical Trials of SWLA, LLC
  • Tandem Clinical Research
  • New Orleans Research Institute - Metropolitan Gastroenterology Associates
  • Clinical Trials of America, Inc.
  • Trialspark - Silverman
  • Gastro Center of Maryland
  • Frederick Gastroenterology Associates, PA an Elligo Health Research Site
  • Woodholme Gastroenterology Associates, P.A.
  • Meridian Clinical Research, LLC
  • Commonwealth Clinical Studies, PLLC.
  • Clinical Research Institute of Michigan
  • Vida Clinical Studies
  • Aa Mrc Llc
  • National Clinical, LLC
  • Gastroenterology Associates of Western Michigan
  • Minnesota Gastroenterology, P.A.
  • Montana Medical Research
  • Methodist Physicians Clinic Diabetes and Endocrine Specialists
  • Heartland Clinical Research, Inc
  • Excel Clinical Research
  • Clinical Research of South Nevada
  • Advanced Biomedical Research of America
  • Digestive Disease Specialists
  • Palm Research Center
  • Garden State Endocrinology
  • AGA Clinical Research Associates LLC
  • Lovelace Scientific Resources, Inc.
  • Long Island Gastrointestinal Research Group LLP
  • Synexus Clinical Research US, Inc.
  • United Health Services Hospitals, Inc.
  • Asheville Gastroenterology Associates
  • University of North Carolina at Chapel Hill
  • Carolina Digestive Health Associates, PA
  • Cumberland Research Associates, LLC
  • Triad Clinical Trials
  • Vidant Multispeciality Clinic - Kinston
  • Diabetes and Endocrinology Consultants, PC
  • PMG Research Salisbury
  • PMG Research of Wilmington, LLC
  • Trial Management Associates, LLC
  • PMG Research of Winston-Salem, LLC
  • The Center for Clinical Research
  • Dayton Gastroenterology, Inc.
  • Diabetes & Endocrinology Associates of Stark County, Inc.
  • Synexus Clinical Research US - Cincinnati
  • Endocrinology Research Associates, Inc.
  • The Ohio State University, Wexner Medical Center
  • Aventiv Research, Inc.
  • Hometown Urgent Care and Research
  • CIC America Clinical Inquest Center Ltd.
  • Hometown Urgent Care and Research
  • Premier Clinical Research d.b.a. STAT Research
  • Family Practice Center of Wadsworth, Inc. DBA New Venture Medical Research
  • Digestive Disease Specialists Inc
  • Memorial Clinical Research
  • Options Health Research, LLC
  • Northwest Gastroenterology Clinic, LLC
  • Family Medical Associates, Research Department
  • Allegheny Endocrinology Associates
  • Preferred Primary Care Physicians, Inc.
  • Frontier Clinical Research, LLC
  • Montgomery Medical, Inc.
  • Preferred Primary Care Physicians
  • Synexus Clinical Research US, Inc.
  • Synexus Clinical Research US, Inc
  • Clinical Trials of South Carolina
  • Gastroenterology Associates, PA
  • Health Concepts
  • Clinsearch
  • Gastro One
  • Quality Medical Research
  • Texas Clinical Research Institute, LLC
  • Avant Research Associates,LLC
  • ClinRx Research, LLC
  • Synexus Clinical Research US, Inc.
  • Biopharma Informatic Inc., Research Center
  • Rodriguez Clinical Trials
  • Amir Ali Hassan, MD, PA
  • Sante Clinical Research
  • Pinnacle Clinical Research
  • Clinical Trials of Texas, Inc.
  • Southern Star Research Institute, LLC
  • Synexus Clinical Research US, Inc.
  • Advanced Research Institute, Inc.
  • Advanced Clinical Research
  • Verity Research Inc.
  • Manassas Clinical Research Centre
  • Cardinal Internal Medicine Associates, PC
  • Washington Gastroenterology PLLC
  • West Virginia University
  • Maffei Centro Medico-Investigacion Clinica Aplicada
  • Hospital Sirio Libanes
  • Centro de Investigaciones Medicas Mar del Plata
  • Instituto Privado de Investigaciones Clínicas de Córdoba
  • Instituto de Investigaciones Clinicas de Rosario
  • Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli
  • Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
  • CIPREC
  • Centro Universitario de Investigacion en Farmacologia Clinic
  • Nepean Hospital
  • Royal Adelaide Hospital
  • Royal Melbourne Hospital
  • Ordination
  • VIVIT Institute, am LKH Feldkirch
  • Privatklinik Wehrle-Diakonissen
  • Landeskrankenhaus Steyr
  • Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,
  • UZ Brussel
  • AZ Sint Lucas Brugge
  • Hospital Universitário Walter Cantídio
  • Instituto de Estudos e Pesquisas Clinicas do Ceará IEP/CE - Oncology
  • Centro de Pesquisa Clinica do Brasil
  • Núcleo de Pesquisa Clínica do Rio Grande do Sul
  • Instituto Catarinense de Endocrinologia e Diabetes (ICED)
  • Scentryphar Pesquisa Clinica Ltda
  • Instituto de Pesquisa Clinica de Campinas
  • CPQuali Pesquisa Clinica Ltda
  • Hospital Universitário João de Barros Barreto
  • IPEC-Instituto de Pesquisa Clinica
  • MHAT Yuliya Vrevska Byala
  • UMHAT - Kaspela- EOOD
  • University of Calgary
  • Alberta Diabetes Institute
  • Central Alberta Research Centre
  • Vancouver General Hospital
  • South Shore Medical Arts
  • The Ottawa Hospital
  • Toronto Digestive Disease Associates
  • Recherche GCP Research
  • Centro Cardiovascular Colombiano Clínica Santa María
  • Rodrigo Botero S.A.S.
  • Centro Cardiovascular y de Diabetes
  • Fundacion BIOS
  • Endocare Ltda.
  • Healthy Medical Center
  • Medplus Medicina Prepagada
  • Asociación Colombiana de Diabetes
  • Fundacion Centro de Investigaciones Clinicas CARDIOMET
  • Centro Medico Imbanaco de Cali S.A.
  • IPS Centro Medico Julian Coronel S.A
  • Gentofte Hospital
  • Gastroenheden, Hvidovre hospital
  • Klinische Forschung Karlsruhe GmbH
  • Studienzentrum Schwittay
  • Klinische Forschung Dresden GmbH
  • Clinical Research Hamburg
  • Israelitisches Krankenhaus
  • KRH Klinikum Siloah
  • First Department of Medicine, University of Szeged
  • Markhot Ferenc Oktatokorhaz es Rendelointezet
  • Hetenyi Geza Hospital
  • Zala Megyei Szent Rafael Korhaz
  • Synexus Budapest DRS
  • Strázsahegy Gyógyszertár Medicina
  • Kumudini Devi Diabetes Research Center; Ramdevrao Hospital
  • King George Hospital
  • Dr. Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre
  • Victoria Hospital
  • Life Care Hospital & Research Centre
  • Diacon Hospital and research Center - Diabetology
  • Rajalakshmi Hospital
  • Vinaya Hospital & Research Centre
  • Bhatia Hospital
  • B. J. Government Medical College and Sassoon General Hospitals
  • Universal Hospital
  • Noble Hospital
  • S.R. Kalla (SRK) Memorial Gastro & General Hospital
  • Diabetic Thyroid and Endocrine Centre
  • Marudhar Hospital
  • Eternal Hospital - Diabetology
  • SMS Hospital
  • Kovai Diabetes Speciality Centre
  • Arthur Asirvatham Hospital
  • M. V Hospital & Research Centre
  • Sir Ganga Ram Hospital
  • Bnai Zion Medical Center
  • Endocrinology & Diabetes Center
  • Chonbuk National University Hospital
  • Diabetes Center
  • Asan Medical Center
  • Kraslava Hospital
  • Polana-D
  • Pauls Stradins Clinical University Hospital, Endokrinologijas nodala
  • Digestive Diseases Centre GASTRO
  • Hospital Sultanah Bahiyah
  • Universiti Sains Malaysia
  • Hospital Taiping
  • Mentrials SA DE CV
  • Clinicos Asociados BOCM SC
  • Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology
  • Centro de Investigación y Atención de Diabetes - Endocrinología y Nutrición
  • Unidad de Investigacion Clinica Cardiometabolica de Occidente, S.C.
  • Consultorio Medico
  • Unidad de Investigación Clínica en Medicina S.C.
  • Centro de Atención e Investigación en Factores de Riesgo Car
  • Centro de Desarrollo Biomédico S.C.P
  • Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV
  • Hospital Cardiologica Aguascalientes
  • Dioderm Instituto de Investigacion
  • Sociedad de Metabolismo y Corazon, S.C.
  • West Visayas State University Medical Center
  • St. Luke's Medical Center
  • Cardinal Santos Medical Center
  • Manila Doctors Hospital, Ermita
  • San Juan De Dios Educational Foundation, Inc.
  • Ospital ng Makati
  • Perpetual Succor Hospital
  • NZOZ Vita Diabetica - Malgorzata Buraczyk
  • Endoskopia Sp. Z O.O.
  • Centrum Medyczne Lukamed
  • Specjalistyczny Gabinet Neurologiczny Marta Banach
  • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
  • Saint-Petersburg City Pokrovskaya Hospital
  • Scientific Institute of Clinical and Experimental Lymphology
  • North-Western State Medical University named after I. I. Mechnikov
  • Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko
  • Kazan State Medical University
  • FSBI National medical endocrinology research centre
  • Moscow Regional Research Clinical Institute named by MF Vladimirski
  • Rostov on Don
  • Rostov State Medical University
  • GUZ Saratov City Clinical Hospital 9
  • Saratov City Clinical Hospital 12
  • National University Hospital
  • Singapore General Hospital
  • Changi General Hospital
  • FARMOVS
  • Wits Clinical Research
  • Synexus Stanza Clincal Reaserch Centre
  • Watermeyer Clinical Research Site
  • Synexus Helderberg Clinical Research Centre
  • Phramongkutklao Hospital
  • Faculty of Medicine, Siriraj Hospital, Mahidol University
  • Maharaj Nakorn Chiang Mai Hospital
  • Ivano-Frankivsk National Medical University
  • Ivano-Frankivsk Central City Clinical Hospital
  • Regional muniRegional municipal institution "Chernivtsi's regional clinical hospital", gastroenterological department, Higher state educational establishment of Ukraine "Bukovinian state medical university", department of internal medicine and infectious
  • Regional Public Organization "Chernivtsi Regional Endocrinology Center"
  • State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine
  • Municipal nonprofit entity of Kharkiv municipal council
  • L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine
  • Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"
  • Communal Institution Kherson City Clinical Hospital
  • Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv
  • Kyiv clinical hospital on railway transport #2 of the "Healthcare Centre" branch of JSC "Ukrainian Railway"
  • Medical Center Universal Clinic Oberig
  • Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit
  • Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University
  • Communal Institution "Odesa Regional Clinical Hospital", Out-patient department
  • Poltava Regional Clinical Hospital
  • Ternopil University Hospital
  • Private Small-Scale Enterprise Medical Centre Pulse
  • Vinnytsia Regional Clinical highly specialized Endocrinology Centre
  • Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia
  • 6th City Clinical Hospital, c. Zaporizhzhia
  • Municipal Institution, City Hospital #7
  • Biomedical Research Centre
  • MAC Clinical Research Manchester
  • Royal Oldham Hospital
  • MAC Research, Exchange House
  • MAC Clinical Research, Monarch House
  • MAC Research
  • MAC Clinical Research, Kaman Court
  • Mid Essex Hospital Services NHS Trust Broomfield Hospital
  • MAC Clinical Research
  • MAC Clinical Research, GAC House

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Treatment Period: Placebo

Treatment Period: Relamorelin 10 μg

Randomized Withdrawal Period: Placebo then Relamorelin 10 μg

Randomized Withdrawal Period: Relamorelin 10 μg then Relamorelin 10 μg

Randomized Withdrawal Period: Relamorelin 10 μg then Placebo

Arm Description

Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.

Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 40 weeks.

Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the Randomized Withdrawal (RW) Period.

Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.

Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.

Outcomes

Primary Outcome Measures

Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period
Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period.

Secondary Outcome Measures

Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
A Nausea Responder was defined as a participant with improvement (decrease) of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Nausea was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no nausea to 10=worst possible nausea. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
An Abdominal Pain Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for abdominal pain at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Abdominal pain was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no abdominal pain to 10=the worst possible abdominal pain and was recorded in an e-diary. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
A Bloating Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Bloating was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no bloating and 10=the worst possible bloating and was recorded in the e-diary. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
A Postprandial Fullness Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Postprandial Fullness was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no feeling of fullness until finishing a meal (best) to 10=feeling full after only a few bites (worst). Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period
Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an e-diary. The DGSSS was derived as the sum of the weekly averages (Week 37 to Week 40) of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous studies.
Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the Treatment Period
The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during the last 4 weeks of the 40-week Treatment Period.
Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period
The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. The average weekly number of vomiting episodes were derived as the average of the weekly number of vomiting episodes in the last 4 weeks of the 40-week Treatment Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period
Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an e-diary. The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). Average weekly scores are derived as the average of the weekly scores from the 6 weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period
The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. Average weekly number of vomiting episodes are derived as the average of the weekly number of vomiting episodes from the six weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Clinical Laboratory values included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Number of Participants With Clinically Meaningful Trends for Vital Signs
Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the results were clinically significant.
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
Number of Participants With Anti-relamorelin Antibody Testing Results
A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay.

Full Information

First Posted
January 24, 2018
Last Updated
November 24, 2021
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT03420781
Brief Title
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03
Official Title
A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
The Relamorelin program is being terminated solely based on a business decision.
Study Start Date
January 24, 2018 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis, Diabetes Mellitus
Keywords
diabetic gastroparesis, vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
467 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Period: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.
Arm Title
Treatment Period: Relamorelin 10 μg
Arm Type
Experimental
Arm Description
Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 40 weeks.
Arm Title
Randomized Withdrawal Period: Placebo then Relamorelin 10 μg
Arm Type
Experimental
Arm Description
Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the Randomized Withdrawal (RW) Period.
Arm Title
Randomized Withdrawal Period: Relamorelin 10 μg then Relamorelin 10 μg
Arm Type
Experimental
Arm Description
Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.
Arm Title
Randomized Withdrawal Period: Relamorelin 10 μg then Placebo
Arm Type
Experimental
Arm Description
Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo injected twice daily
Intervention Type
Drug
Intervention Name(s)
Relamorelin
Intervention Description
Relamorelin 10 μg injected twice daily
Primary Outcome Measure Information:
Title
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period
Description
Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time Frame
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to Week 12 of this study
Title
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Description
The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period.
Time Frame
Week 6 to Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Description
A Nausea Responder was defined as a participant with improvement (decrease) of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Nausea was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no nausea to 10=worst possible nausea. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time Frame
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Title
Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Description
An Abdominal Pain Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for abdominal pain at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Abdominal pain was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no abdominal pain to 10=the worst possible abdominal pain and was recorded in an e-diary. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time Frame
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Title
Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Description
A Bloating Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Bloating was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no bloating and 10=the worst possible bloating and was recorded in the e-diary. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time Frame
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Title
Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
Description
A Postprandial Fullness Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Postprandial Fullness was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no feeling of fullness until finishing a meal (best) to 10=feeling full after only a few bites (worst). Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time Frame
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Title
Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period
Description
Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an e-diary. The DGSSS was derived as the sum of the weekly averages (Week 37 to Week 40) of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous studies.
Time Frame
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)
Title
Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the Treatment Period
Description
The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during the last 4 weeks of the 40-week Treatment Period.
Time Frame
Week 37 to Week 40
Title
Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period
Description
The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. The average weekly number of vomiting episodes were derived as the average of the weekly number of vomiting episodes in the last 4 weeks of the 40-week Treatment Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time Frame
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)
Title
Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period
Description
Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an e-diary. The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). Average weekly scores are derived as the average of the weekly scores from the 6 weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time Frame
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)
Title
Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period
Description
The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. Average weekly number of vomiting episodes are derived as the average of the weekly number of vomiting episodes from the six weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time Frame
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)
Title
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.
Time Frame
First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks)
Title
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Description
Clinical Laboratory values included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Time Frame
Up to 46 weeks
Title
Number of Participants With Clinically Meaningful Trends for Vital Signs
Description
Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the results were clinically significant.
Time Frame
Up to 46 weeks
Title
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
Description
A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Time Frame
Up to 46 weeks
Title
Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
Time Frame
Up to 46 weeks
Title
Number of Participants With Anti-relamorelin Antibody Testing Results
Description
A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay.
Time Frame
Up to 46 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02 Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Participant is not willing or able to abide by the restrictions regarding concomitant medicine use Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03 Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wieslaw Bochenek
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
North Alabama Research Center, LLC
City
Athens
State/Province
Alabama
ZIP/Postal Code
35611
Country
United States
Facility Name
Digestive Health Specialist of the South East
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
G & L Research, LLC
City
Foley
State/Province
Alabama
ZIP/Postal Code
36535
Country
United States
Facility Name
Alabama Medical Group, PC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Del Sol Research Management, LLC
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Phoenix Clinical LLC.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Del Sol Research Management, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Preferred Research Partners, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Applied Research Center of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Unity Health - Searcy Medical Center
City
Searcy
State/Province
Arkansas
ZIP/Postal Code
72143
Country
United States
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
GW Research Inc
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Kindred Medical Institute for Clinical Trials, LLC
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
Aurora Care Clinic, LLC
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Facility Name
Diagnamics Inc.
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
VVCRD Research
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Om Research LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Torrance Clinical Research Institute, Inc.
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Angel City Research Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90026
Country
United States
Facility Name
TriWest Research Associates
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Medical Associates Research Group, Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Syrentis Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Upland Clinical Research
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Colorado Springs Family Practice
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Gastroenterology Associates of Fairfield County, P.C.
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
TrialSpark, Inc.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20017
Country
United States
Facility Name
Innovative Research of West FL, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
West Central Gastroenterology
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
ALL Medical Research LLC
City
Cooper City
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Top Medical Research
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33189
Country
United States
Facility Name
Palmetto Research, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Vida Clinical Trials
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Panax Clinical Research, LLC.
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Savin Medical Group LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
APF Research LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
AMPM Research Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Advanced Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Florida Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
American Research Institute, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Synexus
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
River Birch Research Alliance, LLC
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Gwinnett Research Institute, LLC
City
Buford
State/Province
Georgia
ZIP/Postal Code
30519
Country
United States
Facility Name
Summit Clinical Research, LLC.
City
Carnesville
State/Province
Georgia
ZIP/Postal Code
30521
Country
United States
Facility Name
iResearch Atlanta LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Infinite Clinical Trials
City
Riverdale
State/Province
Georgia
ZIP/Postal Code
30274
Country
United States
Facility Name
Clinical Research Consultants of Atlanta
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Rocky Mountain Diabetes and Osteoporosis Center, PA
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404-7596
Country
United States
Facility Name
Southwest Gastroenterology
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
American Research, LLC
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Health Science Research Center
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
WestGlen Gastrointestinal Consultants
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center - Digestive Health
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Kansas Medical Clinic
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Professional Research Network of Kansas, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Via Christi Clinic, PA
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Tri-State Gastroenterology
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Delta Research Partners
City
Bastrop
State/Province
Louisiana
ZIP/Postal Code
71220
Country
United States
Facility Name
WK Physicians Network
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
Facility Name
Avant Research Associates LLC
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
Facility Name
Cronola LLC
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Clinical Trials of SWLA, LLC
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
New Orleans Research Institute - Metropolitan Gastroenterology Associates
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Clinical Trials of America, Inc.
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Facility Name
Trialspark - Silverman
City
Bowie
State/Province
Maryland
ZIP/Postal Code
20716
Country
United States
Facility Name
Gastro Center of Maryland
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Frederick Gastroenterology Associates, PA an Elligo Health Research Site
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21701
Country
United States
Facility Name
Woodholme Gastroenterology Associates, P.A.
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Facility Name
Commonwealth Clinical Studies, PLLC.
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02302
Country
United States
Facility Name
Clinical Research Institute of Michigan
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Vida Clinical Studies
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Aa Mrc Llc
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
National Clinical, LLC
City
Hamtramck
State/Province
Michigan
ZIP/Postal Code
48212
Country
United States
Facility Name
Gastroenterology Associates of Western Michigan
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Minnesota Gastroenterology, P.A.
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Montana Medical Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Methodist Physicians Clinic Diabetes and Endocrine Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Heartland Clinical Research, Inc
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Excel Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Clinical Research of South Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
Advanced Biomedical Research of America
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Digestive Disease Specialists
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Palm Research Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Garden State Endocrinology
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08723
Country
United States
Facility Name
AGA Clinical Research Associates LLC
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Lovelace Scientific Resources, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Long Island Gastrointestinal Research Group LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
United Health Services Hospitals, Inc.
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Asheville Gastroenterology Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7080
Country
United States
Facility Name
Carolina Digestive Health Associates, PA
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Cumberland Research Associates, LLC
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Triad Clinical Trials
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
Vidant Multispeciality Clinic - Kinston
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Diabetes and Endocrinology Consultants, PC
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
PMG Research Salisbury
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Trial Management Associates, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
PMG Research of Winston-Salem, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Dayton Gastroenterology, Inc.
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
Facility Name
Diabetes & Endocrinology Associates of Stark County, Inc.
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Synexus Clinical Research US - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Endocrinology Research Associates, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43201
Country
United States
Facility Name
The Ohio State University, Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
Aventiv Research, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
CIC America Clinical Inquest Center Ltd.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
Premier Clinical Research d.b.a. STAT Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Family Practice Center of Wadsworth, Inc. DBA New Venture Medical Research
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Facility Name
Digestive Disease Specialists Inc
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Memorial Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Options Health Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Northwest Gastroenterology Clinic, LLC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Family Medical Associates, Research Department
City
Levittown
State/Province
Pennsylvania
ZIP/Postal Code
19056
Country
United States
Facility Name
Allegheny Endocrinology Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Preferred Primary Care Physicians, Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Frontier Clinical Research, LLC
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Montgomery Medical, Inc.
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Clinical Trials of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Gastroenterology Associates, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Clinsearch
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Quality Medical Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Texas Clinical Research Institute, LLC
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Avant Research Associates,LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
ClinRx Research, LLC
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Biopharma Informatic Inc., Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
Rodriguez Clinical Trials
City
Houston
State/Province
Texas
ZIP/Postal Code
77083
Country
United States
Facility Name
Amir Ali Hassan, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Sante Clinical Research
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
Facility Name
Pinnacle Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Southern Star Research Institute, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Advanced Research Institute, Inc.
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Verity Research Inc.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Manassas Clinical Research Centre
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
Cardinal Internal Medicine Associates, PC
City
Woodbridge
State/Province
Virginia
ZIP/Postal Code
22192
Country
United States
Facility Name
Washington Gastroenterology PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Maffei Centro Medico-Investigacion Clinica Aplicada
City
C.a.b.a.
State/Province
Buenos Aires Province
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
Hospital Sirio Libanes
City
Caba
State/Province
Buenos Aires Province
ZIP/Postal Code
C1419AHN
Country
Argentina
Facility Name
Centro de Investigaciones Medicas Mar del Plata
City
Mar del Plata
State/Province
Buenos Aires Province
ZIP/Postal Code
B7600FYK
Country
Argentina
Facility Name
Instituto Privado de Investigaciones Clínicas de Córdoba
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
X5000AAW
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas de Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S200CFK
Country
Argentina
Facility Name
Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
CIPREC
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
1119
Country
Argentina
Facility Name
Centro Universitario de Investigacion en Farmacologia Clinic
City
Corrientes
ZIP/Postal Code
W3410AVV
Country
Argentina
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Ordination
City
Sankt Stefan ob Stainz
State/Province
Styria
ZIP/Postal Code
8511
Country
Austria
Facility Name
VIVIT Institute, am LKH Feldkirch
City
Feldkirch'
State/Province
Vorarlberg
ZIP/Postal Code
6807
Country
Austria
Facility Name
Privatklinik Wehrle-Diakonissen
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Landeskrankenhaus Steyr
City
Steyr
ZIP/Postal Code
4400
Country
Austria
Facility Name
Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Brussel
City
Jette
State/Province
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
AZ Sint Lucas Brugge
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8310
Country
Belgium
Facility Name
Hospital Universitário Walter Cantídio
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60430-370
Country
Brazil
Facility Name
Instituto de Estudos e Pesquisas Clinicas do Ceará IEP/CE - Oncology
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60160-230
Country
Brazil
Facility Name
Centro de Pesquisa Clinica do Brasil
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
71625175
Country
Brazil
Facility Name
Núcleo de Pesquisa Clínica do Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90430-001
Country
Brazil
Facility Name
Instituto Catarinense de Endocrinologia e Diabetes (ICED)
City
Joinville
State/Province
Santa Catarina
ZIP/Postal Code
89201-260
Country
Brazil
Facility Name
Scentryphar Pesquisa Clinica Ltda
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13020-431
Country
Brazil
Facility Name
Instituto de Pesquisa Clinica de Campinas
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13060904
Country
Brazil
Facility Name
CPQuali Pesquisa Clinica Ltda
City
Santa Cecília
State/Province
São Paulo
ZIP/Postal Code
01228-000
Country
Brazil
Facility Name
Hospital Universitário João de Barros Barreto
City
Belém
ZIP/Postal Code
66073-000
Country
Brazil
Facility Name
IPEC-Instituto de Pesquisa Clinica
City
Sao Paulo
ZIP/Postal Code
01223-001
Country
Brazil
Facility Name
MHAT Yuliya Vrevska Byala
City
Byala
State/Province
Ruse
ZIP/Postal Code
7100
Country
Bulgaria
Facility Name
UMHAT - Kaspela- EOOD
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Alberta Diabetes Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
Facility Name
Central Alberta Research Centre
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
South Shore Medical Arts
City
Bridgewater
State/Province
Nova Scotia
ZIP/Postal Code
B4V 2V6
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7W9
Country
Canada
Facility Name
Toronto Digestive Disease Associates
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4YZ
Country
Canada
Facility Name
Recherche GCP Research
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1M 1B1
Country
Canada
Facility Name
Centro Cardiovascular Colombiano Clínica Santa María
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050034
Country
Colombia
Facility Name
Rodrigo Botero S.A.S.
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
050030
Country
Colombia
Facility Name
Centro Cardiovascular y de Diabetes
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Fundacion BIOS
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Endocare Ltda.
City
Bogotá
State/Province
Cundinamarca
ZIP/Postal Code
111111
Country
Colombia
Facility Name
Healthy Medical Center
City
Zipaquirá
State/Province
Cundinamarca
ZIP/Postal Code
250252
Country
Colombia
Facility Name
Medplus Medicina Prepagada
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Asociación Colombiana de Diabetes
City
Teusaquillo
State/Province
Distrito Capital De Bogotá
ZIP/Postal Code
111311
Country
Colombia
Facility Name
Fundacion Centro de Investigaciones Clinicas CARDIOMET
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
660002
Country
Colombia
Facility Name
Centro Medico Imbanaco de Cali S.A.
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760001
Country
Colombia
Facility Name
IPS Centro Medico Julian Coronel S.A
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760035
Country
Colombia
Facility Name
Gentofte Hospital
City
Hellerup
State/Province
Copenhagen
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Gastroenheden, Hvidovre hospital
City
Hvidovre
State/Province
Copenhagen
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Klinische Forschung Karlsruhe GmbH
City
Karlsruhe
State/Province
Baden-Wuertemberg
ZIP/Postal Code
76137
Country
Germany
Facility Name
Studienzentrum Schwittay
City
Böhlen
State/Province
Saxony
ZIP/Postal Code
4564
Country
Germany
Facility Name
Klinische Forschung Dresden GmbH
City
Dresden
State/Province
Saxony
ZIP/Postal Code
1309
Country
Germany
Facility Name
Clinical Research Hamburg
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
Israelitisches Krankenhaus
City
Hamburg
ZIP/Postal Code
22297
Country
Germany
Facility Name
KRH Klinikum Siloah
City
Hannover
ZIP/Postal Code
30459
Country
Germany
Facility Name
First Department of Medicine, University of Szeged
City
Szeged
State/Province
Csonfrád
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Markhot Ferenc Oktatokorhaz es Rendelointezet
City
Eger
State/Province
Heves
ZIP/Postal Code
H-3300
Country
Hungary
Facility Name
Hetenyi Geza Hospital
City
Tószeg
State/Province
Jász-Nagykun-Szolnok
ZIP/Postal Code
H-5004
Country
Hungary
Facility Name
Zala Megyei Szent Rafael Korhaz
City
Zalaegerszeg
State/Province
Zala
ZIP/Postal Code
H-8900
Country
Hungary
Facility Name
Synexus Budapest DRS
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Strázsahegy Gyógyszertár Medicina
City
Budapest
ZIP/Postal Code
H1171
Country
Hungary
Facility Name
Kumudini Devi Diabetes Research Center; Ramdevrao Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500072
Country
India
Facility Name
King George Hospital
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530002
Country
India
Facility Name
Dr. Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380007
Country
India
Facility Name
Victoria Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
Facility Name
Life Care Hospital & Research Centre
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560092
Country
India
Facility Name
Diacon Hospital and research Center - Diabetology
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
359-360
Country
India
Facility Name
Rajalakshmi Hospital
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560097
Country
India
Facility Name
Vinaya Hospital & Research Centre
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575003
Country
India
Facility Name
Bhatia Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400007
Country
India
Facility Name
B. J. Government Medical College and Sassoon General Hospitals
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Universal Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411011
Country
India
Facility Name
Noble Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411013
Country
India
Facility Name
S.R. Kalla (SRK) Memorial Gastro & General Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302001
Country
India
Facility Name
Diabetic Thyroid and Endocrine Centre
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302006
Country
India
Facility Name
Marudhar Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302012
Country
India
Facility Name
Eternal Hospital - Diabetology
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
SMS Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
Kovai Diabetes Speciality Centre
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641009
Country
India
Facility Name
Arthur Asirvatham Hospital
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625020
Country
India
Facility Name
M. V Hospital & Research Centre
City
Lucknow
State/Province
Uttar Prandesh
ZIP/Postal Code
226003
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Endocrinology & Diabetes Center
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-Do
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Diabetes Center
City
Seoul
State/Province
Nowon-gu
ZIP/Postal Code
01757
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Kraslava Hospital
City
Kraslava
State/Province
Kraslavas Nov.
ZIP/Postal Code
5601
Country
Latvia
Facility Name
Polana-D
City
Daugavpils
ZIP/Postal Code
LV5401
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital, Endokrinologijas nodala
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Digestive Diseases Centre GASTRO
City
Riga
ZIP/Postal Code
1006
Country
Latvia
Facility Name
Hospital Sultanah Bahiyah
City
Alor Setar
State/Province
Kedah
ZIP/Postal Code
5460
Country
Malaysia
Facility Name
Universiti Sains Malaysia
City
Kubang Kerian
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Hospital Taiping
City
Taiping
ZIP/Postal Code
34000
Country
Malaysia
Facility Name
Mentrials SA DE CV
City
Cuauhtemoc
State/Province
Cdmx
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Clinicos Asociados BOCM SC
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
03300
Country
Mexico
Facility Name
Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
11650
Country
Mexico
Facility Name
Centro de Investigación y Atención de Diabetes - Endocrinología y Nutrición
City
Durango
State/Province
Guillermina
ZIP/Postal Code
34270
Country
Mexico
Facility Name
Unidad de Investigacion Clinica Cardiometabolica de Occidente, S.C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44150
Country
Mexico
Facility Name
Consultorio Medico
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
C.P. 44210
Country
Mexico
Facility Name
Unidad de Investigación Clínica en Medicina S.C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
C.P. 44670
Country
Mexico
Facility Name
Centro de Atención e Investigación en Factores de Riesgo Car
City
Mexico
State/Province
Mexico DF
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Centro de Desarrollo Biomédico S.C.P
City
Mérida
State/Province
Yucatán
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Hospital Cardiologica Aguascalientes
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Dioderm Instituto de Investigacion
City
Durango
ZIP/Postal Code
34060
Country
Mexico
Facility Name
Sociedad de Metabolismo y Corazon, S.C.
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
West Visayas State University Medical Center
City
IloIlo City
State/Province
IloIlo
ZIP/Postal Code
5000
Country
Philippines
Facility Name
St. Luke's Medical Center
City
Quezon City
State/Province
Metro Manila
ZIP/Postal Code
1100
Country
Philippines
Facility Name
Cardinal Santos Medical Center
City
San Juan City
State/Province
Metro Manila
ZIP/Postal Code
1502
Country
Philippines
Facility Name
Manila Doctors Hospital, Ermita
City
Manila
State/Province
Metropolitan Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
San Juan De Dios Educational Foundation, Inc.
City
Pasay
State/Province
Metropolitan Manila
ZIP/Postal Code
1300
Country
Philippines
Facility Name
Ospital ng Makati
City
Makati City
State/Province
NCR
ZIP/Postal Code
1218
Country
Philippines
Facility Name
Perpetual Succor Hospital
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
NZOZ Vita Diabetica - Malgorzata Buraczyk
City
Bialystok
State/Province
Podlaski
ZIP/Postal Code
15-798
Country
Poland
Facility Name
Endoskopia Sp. Z O.O.
City
Sopot
State/Province
Pomorskie
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Centrum Medyczne Lukamed
City
Chojnice
ZIP/Postal Code
89-600
Country
Poland
Facility Name
Specjalistyczny Gabinet Neurologiczny Marta Banach
City
Krakow
ZIP/Postal Code
30-539
Country
Poland
Facility Name
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
City
Wroclaw
ZIP/Postal Code
51-162
Country
Poland
Facility Name
Saint-Petersburg City Pokrovskaya Hospital
City
St-Petersburg
State/Province
Leningrad Region
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Scientific Institute of Clinical and Experimental Lymphology
City
Novosibirsk
State/Province
Novosibirskaya Oblast
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
North-Western State Medical University named after I. I. Mechnikov
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko
City
Nizhny Novgorod
State/Province
Volga
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Kazan State Medical University
City
Kazan
ZIP/Postal Code
420100
Country
Russian Federation
Facility Name
FSBI National medical endocrinology research centre
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Moscow Regional Research Clinical Institute named by MF Vladimirski
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Rostov on Don
City
Rostov on Don
ZIP/Postal Code
344019
Country
Russian Federation
Facility Name
Rostov State Medical University
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
GUZ Saratov City Clinical Hospital 9
City
Saratov
ZIP/Postal Code
410030
Country
Russian Federation
Facility Name
Saratov City Clinical Hospital 12
City
Saratov
ZIP/Postal Code
410039
Country
Russian Federation
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169856
Country
Singapore
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
FARMOVS
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Wits Clinical Research
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Synexus Stanza Clincal Reaserch Centre
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0122
Country
South Africa
Facility Name
Watermeyer Clinical Research Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0184
Country
South Africa
Facility Name
Synexus Helderberg Clinical Research Centre
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Phramongkutklao Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Faculty of Medicine, Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Ivano-Frankivsk National Medical University
City
Ivano-Frankivsk
State/Province
Ivano-Frankivsk Oblast
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Ivano-Frankivsk Central City Clinical Hospital
City
Ivano-Frankivsk
State/Province
Ivano-Frankivsk Oblast
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Regional muniRegional municipal institution "Chernivtsi's regional clinical hospital", gastroenterological department, Higher state educational establishment of Ukraine "Bukovinian state medical university", department of internal medicine and infectious
City
Chernivtsi
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Regional Public Organization "Chernivtsi Regional Endocrinology Center"
City
Chernivtsi
ZIP/Postal Code
58022
Country
Ukraine
Facility Name
State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine
City
Dnipro
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Municipal nonprofit entity of Kharkiv municipal council
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Communal Institution Kherson City Clinical Hospital
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv
City
Kyiv
ZIP/Postal Code
2002
Country
Ukraine
Facility Name
Kyiv clinical hospital on railway transport #2 of the "Healthcare Centre" branch of JSC "Ukrainian Railway"
City
Kyiv
ZIP/Postal Code
3049
Country
Ukraine
Facility Name
Medical Center Universal Clinic Oberig
City
Kyiv
ZIP/Postal Code
3057
Country
Ukraine
Facility Name
Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit
City
Kyiv
ZIP/Postal Code
4050
Country
Ukraine
Facility Name
Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University
City
Odesa
ZIP/Postal Code
65010
Country
Ukraine
Facility Name
Communal Institution "Odesa Regional Clinical Hospital", Out-patient department
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Poltava Regional Clinical Hospital
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Ternopil University Hospital
City
Ternopil
ZIP/Postal Code
46000
Country
Ukraine
Facility Name
Private Small-Scale Enterprise Medical Centre Pulse
City
Vinnytsia
ZIP/Postal Code
21001
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical highly specialized Endocrinology Centre
City
Vinnytsia
ZIP/Postal Code
21010
Country
Ukraine
Facility Name
Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
6th City Clinical Hospital, c. Zaporizhzhia
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Municipal Institution, City Hospital #7
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Biomedical Research Centre
City
Nottingham
State/Province
East Midland
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
MAC Clinical Research Manchester
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom
Facility Name
Royal Oldham Hospital
City
Oldham
State/Province
Lancashire
ZIP/Postal Code
OL1 2JH
Country
United Kingdom
Facility Name
MAC Research, Exchange House
City
Cannock
State/Province
Staffordshire
ZIP/Postal Code
WS11 0BH
Country
United Kingdom
Facility Name
MAC Clinical Research, Monarch House
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS10 1DU
Country
United Kingdom
Facility Name
MAC Research
City
Barnsley
ZIP/Postal Code
S75 3DL
Country
United Kingdom
Facility Name
MAC Clinical Research, Kaman Court
City
Blackpool
ZIP/Postal Code
FY2 0JH
Country
United Kingdom
Facility Name
Mid Essex Hospital Services NHS Trust Broomfield Hospital
City
Chelmsford
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
MAC Clinical Research
City
Liverpool
ZIP/Postal Code
L34 1BH
Country
United Kingdom
Facility Name
MAC Clinical Research, GAC House
City
Stockton-on-Tees
ZIP/Postal Code
TS17 6EW
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03

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