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Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02

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

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of Type 1 or Type 2 diabetes mellitus
  • Meet the per protocol criteria of diabetic gastroparesis
  • Compliance with diary
  • Compliance with the per protocol study treatment dosing instructions

Exclusion Criteria:

  • Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube
  • Actively experiencing anorexia nervosa, binge-eating, bulimia or other eating disorder at the time of Screening (Visit 1)
  • Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity
  • History of gastrointestinal disorders that may be similar to gastroparesis
  • Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus

Sites / Locations

  • North Alabama Research Center, LLC
  • Synexus Clinical Research US - Simon Williamson Clinic
  • G & L Research, LLC
  • Alabama Medical Group, PC
  • Synexus Clinical Research US, Inc.
  • Applied Research Center of Arkansas
  • Unity Health - Searcy Medical Center
  • GW Research Inc.
  • Diagnamics Inc.
  • Fresno Clinical Research Center
  • Torrance Clinical Research Institute, Inc.
  • Tibor Rubin VA Medical Center
  • Angel City Research Inc.
  • Facey Medical Foundation
  • United Medical Doctors
  • Stanford Hospital, Digestive Health Clinic
  • TriWest Research Associates
  • Optimal Research California
  • Syrentis Clinical Research
  • New Hope Research Development
  • Synexus Clinical Research US, Inc. - Colorado Springs Family Practice
  • Gastroenterology Associates of Fairfield County, P.C.
  • Visionary Investigators Network
  • Clinical Research of West Florida
  • ALL Medical Research LLC
  • Palmetto Research, LLC
  • Vida Clinical Trials
  • Sanchez Clinical Research, Inc.
  • Gastroenterology Group of Naples
  • Synexus
  • Cleveland Clinic Florida - Weston
  • Atlanta Diabetes Associates
  • Emory University
  • River Birch Research Alliance, LLC
  • Gwinnett Research Institute, LLC
  • iResearch Atlanta LLC
  • Clinical Research Consultants of Atlanta
  • Rocky Mountain Diabetes and Osteoporosis Center, PA
  • Synexus Clinical Research US, Inc.
  • Northwestern University Feinberg School of Medicine
  • North Shore University Health System
  • American Research, LLC
  • Gastroenterology of Southern Indiana
  • Health Science Research Center
  • WestGlen Gastrointestinal Consultants
  • Kansas Medical Clinic
  • Professional Research Network of Kansas, LLC
  • Via Christi Clinic, PA
  • Tri-State Gastroenterology
  • WK Physicians Network
  • Avant Research Associates LLC
  • Clinical Trials of SWLA, LLC
  • Tandem Clinical Research
  • Clinical Trials of America, Inc.
  • Trialspark - Sood
  • Capital Diabetes and Endocrine Associates
  • Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
  • Woodholme Gastroenterology Associates, P.A.
  • Meritus Center for Clinical Research
  • Meridian Clinical Research, LLC
  • Commonwealth Clinical Studies, PLLC.
  • Clinical Research Institute of Michigan
  • Aa Mrc Llc
  • Washington University in St. Louis
  • Synexus Clinical Research US, Inc
  • Heartland Clinical Research, Inc
  • USMA Clinical Research, LLC
  • Lovelace Scientific Resources, Inc.
  • Synexus Clinical Research US, Inc.
  • Winthrop-University Hospital
  • Carolina Digestive Health Associates, PA
  • Kinston Medical Specialists, P.A.
  • Diabetes and Endocrinology Consultants, PC
  • PMG Research of Wilmington, LLC
  • PMG Research of Winston-Salem, LLC
  • Synexus Clinical Research US, Inc.
  • Diabetes & Endocrinology Associates of Stark County, Inc.
  • Synexus Clinical Research US - Cincinnati
  • Synexus Clinical Research US, Inc
  • The MetroHealth System MHS
  • Digestive Disease & Surgery Institute
  • The Ohio State University, Wexner Medical Center
  • Aventiv Research, Inc.
  • CIC America Clinical Inquest Center Ltd.
  • Hometown Urgent Care and Research
  • Centennial Health-Synexus
  • Options Health Research, LLC
  • University of Pennsylvania
  • Allegheny Endocrinology Associates
  • Guthrie Clinical Research
  • Frontier Clinical Research, LLC
  • Preferred Primary Care Physicians
  • Care Access Research
  • Synexus Clinical Research US, Inc.
  • Clinical Trials of South Carolina
  • Health Concepts
  • Clinsearch
  • Gastro One
  • East Tennessee Research Institute
  • Texas Clinical Research Institute, LLC
  • ClinRx Research, LLC
  • Baylor College of Medicine Medical Center
  • Biopharma Informatic Inc., Research Center
  • Houston Endoscopy and Research Center, Inc.
  • Rodriguez Clinical Trials
  • Sante Clinical Research
  • Pinnacle Clinical Research
  • Synexus Clinical Research US, Inc.
  • Digestive & Liver Disease Center of San Antonio, PLLC
  • Dwayne O. Williams MD
  • Blue Ridge Medical Research
  • Manassas Clinical Research Centre
  • VA Medical Center McGuire VAMC
  • Washington Gastroenterology PLLC
  • Maffei Centro Medico-Investigacion Clinica Aplicada
  • Hospital Sirio Libanes
  • Centro de Investigaciones Medicas Mar del Plata SRL
  • Instituto Privado de Investigaciones Clínicas de Córdoba
  • Instituto de Investigaciones Clinicas de Rosario
  • Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli
  • Clinica Mayo - Infectious DiseasesClínica Mayo de Urgencias
  • CIPREC
  • Centro Universitario de Investigacion en Farmacologia Clinic
  • CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian
  • Ordination
  • VIVIT Institute, am LKH Feldkirch
  • Privatklinik Wehrle-Diakonissen
  • Oö. Gesundheits- und Spitals-AG/LKH Steyr
  • AZ Sint Lucas Brugge
  • Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,
  • UZ Brussel
  • Hospital Universitario Walter Cantidio
  • Centro de Pesquisa Clinica do Brasil
  • Hospital Universitario Joao de Barros Barreto
  • Núcleo de Pesquisa Clínica do Rio Grande do Sul
  • Instituto Catarinense de Endocrinologia e Diabetes (ICED)
  • Scentryphar Pesquisa Clinica Ltda
  • Instituto de Pesquisa Clinica em Campinas
  • CPQuali Pesquisa Clinica Ltda
  • Instituto de Estudos E Persquisas Clinicas do Ceará - IEP/CE - Oncology
  • Instituto de Pesquisa ClÍnica e Medicina AvanCada Ltda
  • University of Calgary
  • Alberta Diabetes Institute
  • Gordon and Leslie Diamond Health Care Centre
  • Eastern Health
  • South Shore Medical Arts
  • The Ottawa Hospital
  • Sunnybrook Health Science Centre
  • Toronto Western Hospital, University Health Network
  • Toronto Liver Centre
  • Toronto Digestive Disease Associates
  • CISSS de la Monteregie-Centre
  • Recherche GCP Research
  • Centre Hospitalier de l'Universite de Montreal - CHUM
  • Central Alberta Research Centre
  • Centro Cardiovascular Colombiano Clínica Santa María
  • Rodrigo Botero S.A.S.
  • Centro Cardiovascular y de Diabetes
  • Fundacion Bios
  • Asociación Colombiana de Diabetes
  • Healthy Medical Center
  • Medplus Mp
  • Endocare Ltda.
  • Fundacion Centro de Investigaciones Clinicas CARDIOMET
  • IPS Centro Medico Julian Coronel S.A
  • Centro Medico Imbanaco de Cali S.A.
  • Gastroenheden, Hvidovre hospital
  • Endocrinology, Aalborg University Hospital
  • Center for Clinical Metabolic Research
  • Klinische Forschung Karlsruhe GmbH
  • Studienzentrum Schwittay
  • Klinische Forschung Dresden GmbH
  • Clinical Research Unit
  • Clinical Research Hamburg
  • Israelitisches Krankenhaus
  • KRH Klinikum Siloah
  • Markhot Ferenc Oktatokorhaz es Rendelointezet
  • BKS Research Kft Synexus AS
  • Hetenyi Geza Hospital
  • Zala Megyei Szent Rafael Korhaz
  • Synexus Budapest DRS
  • Strázsahegy Gyógyszertár Medicina
  • SYNEXUS Magyarorszag Kft Debrecen A.S.
  • Synexus Magyarország kft. Gyula DRS
  • Szegedi Tudomanyegyetem
  • Synexus Magyarorszag Kft
  • Polana-D
  • Kraslava Hospital
  • Pauls Stradins Clinical University Hospital, Endokrinologijas nodala
  • Digestive Diseases Centre GASTRO
  • Medical and Nutritional Trials
  • Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology
  • Centro de Atención e Investigación en Factores de Riesgo Car
  • Clinicos Asociados BOCM SC
  • Unidad de Investigacion Clinica Cardiometabolica de Occidente
  • Consultorio Medico
  • Unidad de Investigación Clínica en Medicina S.C.
  • Centro de Desarrollo Biomedico 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.
  • Saint-Petersburg City Pokrovskaya Hospital
  • Scientific Institute of Clinical and Experimental Lymphology
  • GUZ Saratov City Clinical Hospital 9
  • 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
  • North-Western State Medical University named after I. I. Mechnikov
  • Saratov City Clinical Hospital 12
  • FARMOVS
  • Wits Clinical Research
  • Synexus Stanza Clinical Research Centre
  • Watermeyer Clinical Research Site
  • Synexus Helderberg Clinical Research Centre
  • TREAD Research
  • MAC Clinical Research Manchester
  • Synexus Lancashire Dedicated Research Centre
  • Royal Oldham Hospital
  • MAC Research, Exchange House
  • University Hospitals of North Midlands
  • Royal Wolverhampton NHS Trust
  • MAC Clinical Research, Monarch House
  • MAC Research
  • MAC Clinical Research
  • Synexus Wales Clinical Research Centre
  • Mid Essex Hospital Services NHS Trust Broomfield Hospital
  • Western General Hospital
  • Synexus Merseyside Dedicated Research Centre
  • MAC Clinical Research
  • Wingate Institute of Neurogastroenterology and Barts Health Trust and the Royal London Hospital
  • MAC Clinical Research, GAC House
  • Synexus Manchester Clinical Research Centre
  • Royal Victoria Infirmary: Clinical Research Facility
  • Biomedical Research Centre
  • Synexus Hexham Dedicated Research Centre
  • Synexus North Tees Clinical Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Relamorelin 10 μg

Arm Description

Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.

Following a 2-week placebo run-in, participants received relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 12 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)
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.
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 12-week Treatment Period.

Secondary Outcome Measures

Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 12-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.
Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 12-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.
Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 12-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.
Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 12-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).
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 tests 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 abnormal 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 by Visit
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. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.

Full Information

First Posted
February 2, 2018
Last Updated
July 15, 2021
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT03426345
Brief Title
Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02
Official Title
A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
The Relamorelin program is being terminated solely based on a business decision
Study Start Date
February 16, 2018 (Actual)
Primary Completion Date
July 16, 2020 (Actual)
Study Completion Date
July 16, 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
No

5. Study Description

Brief Summary
This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
311 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
Arm Title
Relamorelin 10 μg
Arm Type
Experimental
Arm Description
Following a 2-week placebo run-in, participants received relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo injected subcutaneously twice daily.
Intervention Type
Drug
Intervention Name(s)
Relamorelin
Intervention Description
Relamorelin 10 μg injected twice daily for 12 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)
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.
Time Frame
Baseline (Day-14 to Day-1) to Week 12
Title
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 12-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 12-week 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 12-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.
Time Frame
Baseline (Day-14 to Day-1) 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 12-week 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 12-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.
Time Frame
Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Title
Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 12-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.
Time Frame
Baseline (Day-14 to Day-1) 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 12-week 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 12-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).
Time Frame
Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
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
Up to approximately 16 weeks
Title
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Description
Clinical Laboratory tests 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 12 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 abnormal results were clinically significant.
Time Frame
Up to 12 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 12 weeks
Title
Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
Time Frame
Baseline (Day 1) up to 12 weeks
Title
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit
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. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.
Time Frame
Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Type 1 or Type 2 diabetes mellitus Meet the per protocol criteria of diabetic gastroparesis Compliance with diary Compliance with the per protocol study treatment dosing instructions Exclusion Criteria: Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube Actively experiencing anorexia nervosa, binge-eating, bulimia or other eating disorder at the time of Screening (Visit 1) Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity History of gastrointestinal disorders that may be similar to gastroparesis Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wieslaw (Wes) Bochenek, MD, PhD
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
Synexus Clinical Research US - Simon Williamson Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
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
Synexus Clinical Research US, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
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
Unity Health - Searcy Medical Center
City
Searcy
State/Province
Arkansas
ZIP/Postal Code
72143
Country
United States
Facility Name
GW Research Inc.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Diagnamics Inc.
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Fresno Clinical Research Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Torrance Clinical Research Institute, Inc.
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Tibor Rubin VA Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Angel City Research Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90026
Country
United States
Facility Name
Facey Medical Foundation
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
United Medical Doctors
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Facility Name
Stanford Hospital, Digestive Health Clinic
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
TriWest Research Associates
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Optimal Research California
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Syrentis Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
New Hope Research Development
City
Whittier
State/Province
California
ZIP/Postal Code
90603
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
06824
Country
United States
Facility Name
Visionary Investigators Network
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
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
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
Sanchez Clinical Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Synexus
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Cleveland Clinic Florida - Weston
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
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
iResearch Atlanta LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
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
Synexus Clinical Research US, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
North Shore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
American Research, LLC
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Gastroenterology of Southern Indiana
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
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
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
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
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
Clinical Trials of America, Inc.
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Facility Name
Trialspark - Sood
City
Bowie
State/Province
Maryland
ZIP/Postal Code
20716
Country
United States
Facility Name
Capital Diabetes and Endocrine Associates
City
Camp Springs
State/Province
Maryland
ZIP/Postal Code
20746
Country
United States
Facility Name
Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
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
Meritus Center for Clinical Research
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
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
Aa Mrc Llc
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Heartland Clinical Research, Inc
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
USMA Clinical Research, LLC
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07201
Country
United States
Facility Name
Lovelace Scientific Resources, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
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
Winthrop-University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Carolina Digestive Health Associates, PA
City
Davidson
State/Province
North Carolina
ZIP/Postal Code
28036
Country
United States
Facility Name
Kinston Medical Specialists, P.A.
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 of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
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
Synexus Clinical Research US, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
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
Synexus Clinical Research US, Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
The MetroHealth System MHS
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109-1998
Country
United States
Facility Name
Digestive Disease & Surgery Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
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
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
Centennial Health-Synexus
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73111
Country
United States
Facility Name
Options Health Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny Endocrinology Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Guthrie Clinical Research
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Frontier Clinical Research, LLC
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
Care Access Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
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
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
East Tennessee Research Institute
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Texas Clinical Research Institute, LLC
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
ClinRx Research, LLC
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Baylor College of Medicine Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Biopharma Informatic Inc., Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
Houston Endoscopy and Research Center, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Rodriguez Clinical Trials
City
Houston
State/Province
Texas
ZIP/Postal Code
77083
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
Synexus Clinical Research US, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Digestive & Liver Disease Center of San Antonio, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
Dwayne O. Williams MD
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Blue Ridge Medical Research
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Manassas Clinical Research Centre
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
VA Medical Center McGuire VAMC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Washington Gastroenterology PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
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 SRL
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 - Infectious DiseasesClínica Mayo de Urgencias
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
CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian
City
Córdoba
ZIP/Postal Code
X5000BNB
Country
Argentina
Facility Name
Ordination
City
Sankt Stefan
State/Province
Steiermark
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
Oö. Gesundheits- und Spitals-AG/LKH Steyr
City
Steyr
ZIP/Postal Code
4400
Country
Austria
Facility Name
AZ Sint Lucas Brugge
City
Brugge
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
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
Hospital Universitario Walter Cantidio
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60430-372
Country
Brazil
Facility Name
Centro de Pesquisa Clinica do Brasil
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
71625175
Country
Brazil
Facility Name
Hospital Universitario Joao de Barros Barreto
City
Belem
State/Province
Para
ZIP/Postal Code
66073-000
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 em Campinas
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13060-080
Country
Brazil
Facility Name
CPQuali Pesquisa Clinica Ltda
City
Santa Cecília
State/Province
Sao Paulo
ZIP/Postal Code
01228-000
Country
Brazil
Facility Name
Instituto de Estudos E Persquisas Clinicas do Ceará - IEP/CE - Oncology
City
Fortaleza
ZIP/Postal Code
60160-230
Country
Brazil
Facility Name
Instituto de Pesquisa ClÍnica e Medicina AvanCada Ltda
City
SÃo Paulo
ZIP/Postal Code
01223-001
Country
Brazil
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
Gordon and Leslie Diamond Health Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada
Facility Name
Eastern Health
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
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
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Toronto Western Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Toronto Digestive Disease Associates
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4YZ
Country
Canada
Facility Name
CISSS de la Monteregie-Centre
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Recherche GCP Research
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1M 1B1
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal - CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Central Alberta Research Centre
City
Red Deer
ZIP/Postal Code
T4N 6V7
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
Medellin
State/Province
Antioquia
ZIP/Postal Code
50030
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
Asociación Colombiana de Diabetes
City
Bogotá
State/Province
Cundinamarca
ZIP/Postal Code
111311
Country
Colombia
Facility Name
Healthy Medical Center
City
Zipaquira
State/Province
Cundinamarca
ZIP/Postal Code
250252
Country
Colombia
Facility Name
Medplus Mp
City
Bogota
State/Province
Distrito Capital De Bogotá
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Endocare Ltda.
City
Bogota
State/Province
Distrito Capital De Bogotá
ZIP/Postal Code
111111
Country
Colombia
Facility Name
Fundacion Centro de Investigaciones Clinicas CARDIOMET
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
660002
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
Centro Medico Imbanaco de Cali S.A.
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760042
Country
Colombia
Facility Name
Gastroenheden, Hvidovre hospital
City
Hvidovre
State/Province
Copenhagen
ZIP/Postal Code
2605
Country
Denmark
Facility Name
Endocrinology, Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
DK-9000
Country
Denmark
Facility Name
Center for Clinical Metabolic Research
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Klinische Forschung Karlsruhe GmbH
City
Karlsruhe
State/Province
Baden-SWürttemberg
ZIP/Postal Code
76199
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 Unit
City
Giessen
ZIP/Postal Code
32392
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
Markhot Ferenc Oktatokorhaz es Rendelointezet
City
Eger
State/Province
Heves
ZIP/Postal Code
H-3300
Country
Hungary
Facility Name
BKS Research Kft Synexus AS
City
Hatvan
State/Province
Heves
ZIP/Postal Code
3000
Country
Hungary
Facility Name
Hetenyi Geza Hospital
City
Szolnok
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
SYNEXUS Magyarorszag Kft Debrecen A.S.
City
Debrecen
ZIP/Postal Code
4025
Country
Hungary
Facility Name
Synexus Magyarország kft. Gyula DRS
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Synexus Magyarorszag Kft
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Polana-D
City
Daugavpils
ZIP/Postal Code
5401
Country
Latvia
Facility Name
Kraslava Hospital
City
Kraslava
ZIP/Postal Code
5601
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
Medical and Nutritional Trials
City
Cuauhtemoc
State/Province
Cdmx
ZIP/Postal Code
06700
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 Atención e Investigación en Factores de Riesgo Car
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Clinicos Asociados BOCM SC
City
Portales
State/Province
Distrito Federal
ZIP/Postal Code
03300
Country
Mexico
Facility Name
Unidad de Investigacion Clinica Cardiometabolica de Occidente
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 Desarrollo Biomedico S.C.P.
City
Mérida
State/Province
Yucatan
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
C.P. 91900
Country
Mexico
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
Novosibirsk Oblast
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
GUZ Saratov City Clinical Hospital 9
City
Saratov
State/Province
Saratov Region
ZIP/Postal Code
410030
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
420012
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
North-Western State Medical University named after I. I. Mechnikov
City
Saint-Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Saratov City Clinical Hospital 12
City
Saratov
ZIP/Postal Code
410039
Country
Russian Federation
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 Clinical Research Centre
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0122
Country
South Africa
Facility Name
Watermeyer Clinical Research Site
City
Silverton
State/Province
Gauteng
ZIP/Postal Code
184
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
TREAD Research
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
MAC Clinical Research Manchester
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom
Facility Name
Synexus Lancashire Dedicated Research Centre
City
Chorley
State/Province
Lancashire
ZIP/Postal Code
PR7 7NA
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
University Hospitals of North Midlands
City
Stoke on Trent
State/Province
Staffordshire
ZIP/Postal Code
ST6 8DG
Country
United Kingdom
Facility Name
Royal Wolverhampton NHS Trust
City
Wolverhampton
State/Province
West Midlands
ZIP/Postal Code
WV10 0QP
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
City
Blackpool
ZIP/Postal Code
FY2 0JH
Country
United Kingdom
Facility Name
Synexus Wales Clinical Research Centre
City
Cardiff
ZIP/Postal Code
CF15 9SS
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
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Synexus Merseyside Dedicated Research Centre
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
MAC Clinical Research
City
Liverpool
ZIP/Postal Code
L34 1BH
Country
United Kingdom
Facility Name
Wingate Institute of Neurogastroenterology and Barts Health Trust and the Royal London Hospital
City
London
ZIP/Postal Code
E1 2AJ
Country
United Kingdom
Facility Name
MAC Clinical Research, GAC House
City
Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom
Facility Name
Synexus Manchester Clinical Research Centre
City
Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
Facility Name
Royal Victoria Infirmary: Clinical Research Facility
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Biomedical Research Centre
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Synexus Hexham Dedicated Research Centre
City
Stockton-on-Tees
ZIP/Postal Code
TS19 8PE
Country
United Kingdom
Facility Name
Synexus North Tees Clinical Research Centre
City
Stockton-on-Tees
ZIP/Postal Code
TS19 8PE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02

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