Back to resultsA Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04
Primary Purpose
Gastroparesis, Diabetes Mellitus
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Relamorelin
Sponsored by
About this trial
This is an interventional treatment trial for Gastroparesis focused on measuring diabetic gastroparesis, vomiting
Eligibility Criteria
Inclusion Criteria:
Two different groups of participants may enter into the study:
Rollover Participants
Participants who were not randomization-eligible at the end of the Run-in Period of lead-in studies RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) are eligible to be randomized in the study if all of the following criteria apply:
•In the lead-in studies, participants must have met all screening visit and Run-in Period criteria for randomization into the Treatment Period (including compliance with dosing, entry of diary data into the Diabetic Gastroparesis Symptom Severity Diary (DGSSD)) except that:
- They had zero vomiting episodes and an average daily Diabetic Gastroparesis Symptom Severity Score (DGSSS) of ≥12 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device; OR
- They had vomiting episodes and an average daily DGSSS of ≥12 but <16 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device
De Novo Participants
- Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) of at least 5 years' duration, with controlled and stable blood glucose levels and hemoglobin A1c (HBA1c) ≤11%
- DG defined as at least a 3-month history prior to Screening of symptoms (one of which must be nausea) on an ongoing basis that are suggestive of gastroparesis (GP) (e.g., nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety)
- Compliance with the entry of data into the hand-held electronic device during the Run-in Period
- Compliance with administration of subcutaneous (SC) twice daily injections during the Run-in Period
- The average of the daily DGSSS from the 2-week, Run-in Period must be ≥12
Exclusion Criteria:
Both Rollover and De Novo Participants
•Participants with a known allergy or hypersensitivity to the study treatments and their excipients (i.e., mannitol or phenol)
Rollover Participants
•Participants will be excluded from this study if any of the lead-in study exclusion criteria apply at the Screening Visit and at the end of the Run-in Period for randomization into the Treatment Period of studies RLM-MD-01 and RLM-MD-02, except as specified in the inclusion criteria
De Novo Participants
- History of anorexia nervosa, binge-eating, bulimia, or other eating disorder within 5 years of the Screening Visit
- History of intestinal malabsorption or pancreatic exocrine insufficiency
- History of belching disorders, other nausea and vomiting disorders
- Gastric or duodenal ulcer within 3 months of Screening
- History of malignancy in the 3 years prior to Screening, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
- Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression
- Use of metoclopramide, domperidone, prucalopride, macrolide antibiotics (e.g., erythromycin, clarithromycin, azithromycin), or other drugs considered to be GI promotility agents for at least 10 days prior to the start of the Run-in Period
- Currently taking opiates, or expecting to use opiates during the course of the clinical study
- Treatment with glucagon-like peptide-1 (GLP-1) agonist for at least 6 weeks prior to the start of the Run-in Period
- History of pyloric injection of botulinum toxin within 6 months of screening
- History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure (a history of diagnostic endoscopy is not exclusionary)
- Randomization in any previous study in which relamorelin was a treatment
- Allergic to, or intolerant of egg, wheat, milk, or algae, as these are components of the gastric emptying breath test (GEBT) study meal
Sites / Locations
- Pinnacle Research Group
- North Alabama Research Center, LLC
- Simon Williamson Clinic
- Digestive Health Specialist of the South East
- G & L Research, LLC
- Avant Research Associates
- Alabama Medical Group, PC
- Phoenix Clinical LLC.
- Del Sol Research Management, LLC
- Del Sol Research Management, LLC
- Synexus Clinical Research US, Inc.
- 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
- TriWest Research Associates
- Diagnamics Inc.
- VVCRD Research
- University of California San Diego
- Om Research LLC
- Torrance Clinical Research Institute, Inc.
- Angel City Research Inc.
- Stanford Hospital
- Optimal Research California
- Medical Associates Research Group, Inc
- Syrentis Clinical Research
- Upland Clinical Research
- Synexus Clinical Research US, Inc.
- New Hope Research Development
- Peak Gastroenterology Associates
- Synexus
- Gastroenterology Associates of Fairfield County, P.C.
- Medical Research Center of Connecticut, LLC
- Innovative Research of West FL, Inc.
- Clinical Research of West Florida
- ALL Medical Research, LLC
- Top Medical Research
- Palmetto Research, LLC
- Vida Clinical Trials
- Nature Coast Clinical Research
- Savin Medical Group LLC
- APF Research LLC
- AMPM Research Clinic
- Advanced Medical Research Institute
- Florida Research Center, Inc.
- American Research Institute, Inc
- Gastroenterology Group of Naples
- Sensible Healthcare
- Synexus
- Atlanta Diabetes Associates
- 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
- North Shore University Health System
- Southwest Gastroenterology
- MediSphere Medical Research Center, LLC
- Synexus Clinical Research US, Inc.
- 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
- St. Elizabeth Healthcare â€" Clinical Research Institute
- University of Louisville
- WK Physicians Network
- Avant Research Associates LLC
- Cronola LLC
- Clinical Trials of SWLA, LLC
- Tandem Clinical Research
- Clinical Trials of America, Inc.
- Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
- Gastro Center of Maryland
- Frederick Gastroenterology Associates, PA an Elligo Health Research Site
- Woodholme Gastroenterology Associates, P.A.
- Meritus Center for Clinical Research
- Meridian Clinical Research, LLC
- Clinical Research Institute of Michigan
- Vida Clinical Studies
- Aa Mrc, Llc
- National Clinical, LLC
- Gastroenterology Associates of Western Michigan, West Michigan Clinical Research Center
- MNGI Digestive Health
- Synexus Clinical Research US, Inc.
- Synexus Clinical Research US, Inc
- Montana Medical Research
- Diabetes and Endocrine Associates, P.C.
- Heartland Clinical Research, Inc
- Excel Clinical Research
- Clinical Research of South Nevada - CROSN
- Advanced Biomedical Research of America
- Digestive Disease Specialists
- Palm Research Center
- Garden State Endocrinology LLC
- Synexus Clinical Research US, Inc.
- AGA Clinical Research Associates, LLC
- Lovelace Scientific Resources, Inc.
- CHEAR Center LLC
- Long Island Gastrointestinal Research Group LLP
- United Health Services Hospitals, Inc.
- Asheville Gastroenterology Associates
- University of North Carolina at Chapel Hill
- Carolinas Healthcare-Charlotte
- 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
- Synexus Clinical Research US, Inc.
- Dayton Gastroenterology,Inc.
- Diabetes & Endocrinology Associates of Stark County, Inc.
- Synexus Clinical Research US - Cincinnati
- Synexus Clinical Research US, Inc
- 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.
- Centennial Health-Synexus
- 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.
- Guthrie Clinical Research
- Frontier Clinical Research, LLC
- Frontier Clinical Research, LLC
- Preferred Primary Care Physicians
- Synexus Clinical Research US, Inc.
- Synexus Clinical Research US, Inc
- Clinical Trials of South Carolina
- Carolina Medical Research
- Gastroenterology Associates, PA
- Synexus Clinical Research
- Health Concepts
- Clinsearch
- Gastroenterology Centers of the Midsouth
- East Tennessee Research Institute
- Quality Medical Research
- Texas Clinical Research Institute, LLC
- DiscoveResearch, Inc.
- ClinRx Research, LLC
- Baylor College of Medicine Medical Center
- Biopharma Informatic Inc., Research Center
- Houston Endoscopy and Research Center, Inc.
- Rodriguez Clinical Trials
- Amir Hassan, MD, PA
- Sante Clinical Research
- Pinnacle Clinical Research
- Clinical Trials of Texas, Inc.
- Sagact Pllc.
- Synexus Clinical Research US, Inc.
- Synexus Clinical Research US, Inc.
- Synexus Clinical Research US, Inc.
- Advanced Research Institute, Inc.
- Advanced Clinical Research
- Verity Research Inc.
- Blue Ridge Medical Research
- Manassas Clinical Research Centre
- VA Medical Center McGuire VAMC
- Washington Gastroenterology PLLC
- West Virginia University
- Consultorios Asociados de Endocrinologia e Investigación Cl
- Hospital Sirio Libanes
- Centro de Investigaciones Medicas Mar del Plata SRL
- CIPREC
- Instituto de Investigaciones Clinicas de Rosario
- Instituto Medico Catamarca-I.ME.C
- Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
- CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian
- Centro Universitario de Investigacion en Farmacologia Clinic
- Instituto Privado de Investigaciones Clinicas de Cordoba
- Nepean Hospital
- Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated
- Royal Melbourne Hospital
- Ordination
- VIVIT Institute, am LKH Feldkirch
- Privatklinik wehlre-Diakonissen
- Oö. Gesundheits- und Spitals-AG/LKH Steyr
- Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,
- UZ Brussel
- AZ Sint Lucas Brugge
- Hospital Universitário Walter Cantídio
- Centro de Pesquisa Clinica do Brasil
- Hospital Universitário João de Barros Barreto - UFPA
- Núcleo de Pesquisa Clínica do Rio Grande do Sul
- Instituto Catarinense de Endocrinologia e Diabetes (ICED)
- Scentryphar Pesquisa Clínica Ltda
- Instituto de Pesquisa Clinica em Campinas
- Instituto de Estudos e Pesquisas Clinicas do Ceara IEP/CE - Oncology
- IPEC-Instituto de Pesquisa Clinica
- CPQuali Pesquisa Clinica Ltda
- MHAT Yuliya Vrevska Byala
- UMHAT - Kaspela- EOOD
- Medical Center Asklepion - Humane Medicine Research EOOD
- Alexandrovska University Hospital
- University of Calgary
- Central Alberta Research Centre
- Vancouver General Hospital
- Patient research centre
- South Shore Medical Arts
- The Ottawa Hospital
- Toronto Digestive Disease Associates, Inc.
- Recherche GCP Research
- Centro Cardiovascular Colombiano Clínica Santa María
- Rodrigo Botero S.A.S.
- Centro Cardiovascular y de Diabetes
- Fundación del Caribe para la InvestigacionBiomédica-Fundación BIOS
- Asociación Colombiana de Diabetes
- Healthy Medical Center
- Endocare Ltda.
- Medplus Centro de Recuperacion Integral S.A.S.
- Centro de Investigaciones Clínicas IPS CARDIOMET Pereira
- IPS Centro Medico Julian Coronel S.A
- Centro Medico Imbanaco de Cali S.A.
- Steno Diabetes Center Copenhagen
- Gastroenheden, Hvidovre hospital
- Klinische Forschung Karlsruhe GmbH
- Studienzentrum Schwittay
- Klinische Forschung Dresden GmbH
- Clinical Research Hamburg
- Israelitisches Krankenhaus
- KRH Klinikum Siloah
- Markhot Ferenc Oktatokorhaz es Rendelointezet
- Hetenyi Geza Hospital
- Zala Megyei Szent Rafael Korhaz
- Strázsahegy Gyógyszertár Medicina
- Szegedi TudomanyegyetemSzent-Gyorgyi Albert Klinikai Kozpont és Altalanos Orvostudomanyi Kar Belgyogyaszati Klinika
- Kumudini Devi Diabetes Research Center; Ramdevrao Hospital
- King George Hospital
- Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre - Gasterentrology
- Zydus Hospital
- Lifecare Clinic and Research Centre - Internal Med/Diabetology
- Diacon Hospital and research Center - Diabetology
- Victoria Hospital Bangalore Medical College and Research Institute
- Rajalakshmi Hospital
- Bhatia Hospital
- B. J. Government Medical College and Sassoon General Hospitals
- Universal Hospital
- Noble Hospital
- S R Kalla (SRK) Memorial Gastro & General Hospital
- Marudhar Hospital
- Eternal Hospital - Diabetology
- SMS Hospital
- M.V. Hospital for Diabetes & Diabetes Research Centre
- Kovai Diabetes Speciality Centre
- Arthur Asirvatham Hospital
- M V Hospital & Research Centre
- Sir Ganga Ram Hospital (SGRH)
- Vinaya Hospital & Research Centre
- Bnei-Zion MC
- Chonbuk National University Hospital
- Sanggye Paik Hospital, Inje University College of Medicine
- Asan Medical Center
- Kraslava Hospital
- Polana-D
- Pauls Stradins Clinical University Hospital, Endokrinologijas nodala
- Digestive Diseases Centre GASTRO
- Hospital Sultanah Bahiyah
- Clinical Investigation Centre
- Clinical Trial Unit, School of Medical Sciences, Health Campus, Hospital 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 Atención e Investigación en Factores de Riesgo Car
- Unidad de Investigacion Clinica Cardiometabolica de Occidente
- Consultorio particular
- Unidad de Investigación Clínica en Medicina S.C/
- Centro de Desarrollo Biomédico S.C.P
- Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV
- Hospital Cardiologica Aguascalientes
- Dioderm Instituto de Investigacion
- CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición)
- Sociedad de Metabolismo y Corazon S.C.
- West Visayas State University Medical Center
- Cardinal Santos Medical Center
- Manila Doctors Hospital, Ermita
- San Juan De Dios Educational Foundation, Inc.
- Ospital ng Makati
- Perpetual Succor Hospital
- St. Luke's Medical Center
- Specjalistyczny Gabinet Neurologiczny Marta Banach
- CenterMed Krakow Ltd
- Centrum Medyczne Lukamed
- Saint-Petersburg City Pokrovskaya Hospital
- GUZ Saratov City Clinical Hospital 9
- Scientific Institute of Clinical and Experimental Lymphology
- Rostov on Don
- National University Hospital
- Changi General Hospital
- Singapore General Hospital
- FARMOVS
- Wits Clinical Research
- Synexus Stanza Clinical Research Centre
- Watermeyer Clinical Research Site
- Synexus Helderberg Clinical Research Centre
- Hospital Universitario Principe de Asturias
- Phramongkutklao Hospital
- Faculty of Medicine, Siriraj Hospital, Mahidol University
- Maharaj Nakorn Chiang Mai Hospital
- State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine
- Municipal Institution, City Hospital #7, polyclinic department, c. Zaporizhzhia
- Chernivtsi Regional Clinical Hospital
- Regional Municipal noncommercial Enterprise "Chernivtsi Regional Endocrinology Center", Polyclinic department, Higher State Educational Establishment of Ukraine "Bukovinian State Medical University", Department of Clinical Immunology, Allergology and Endo
- Ivano-Frankivsk National Medical University
- Ivano-Frankivsk Central City Clinical Hospital
- Municipal nonprofit entity of Kharkiv municipal council
- Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"
- Communal Institution Kherson City Clinical Hospital
- Kyiv Railway Clinical Hospital No-2 of Branch of Healthcare Center of the PJSC Ukrainian Railway , Endocrynology Department
- 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
- Poltava Regional Clinical Hospital
- Private Small-Scale Enterprise Medical Centre Pulse
- Vinnytsia Regional Clinical highly specialized Endocrinology Centre
- Municipal Institution 6th City Clinical Hospital, Dept of Gastroenterology
- Biomedical Research Centre
- MAC Clinical Research Manchester
- Royal Oldham Hospital
- MAC Clinical Research
- MAC Research, Exchange House
- University Hospitals of North Midlands
- MAC Clinical Research, Monarch House
- MAC Research
- MAC Clinical Research, Kaman Court
- Mid Essex Hospital Services NHS Trust Broomfield Hospital
- MAC Clinical Research, GAC House
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Relamorelin 10 μg
Arm Description
Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
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 of the previous study or the run-in period of this study for new participants.
Change From Baseline to Week 52 in the Weekly Average DGSSS
Participants assessed the severity of diabetic gastroparesis symptoms daily using the 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). The average weekly scores at Week 52 were the average of the DGSSS scores from Week 49 to Week 52. 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 study or the run-in period of this study for new participants.
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 participant 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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03383146
Brief Title
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04
Official Title
A 52-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
November 2021
Overall Recruitment Status
Terminated
Why Stopped
The Relamorelin program is being terminated solely based on a business decision.
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
November 5, 2020 (Actual)
Study Completion Date
November 5, 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 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.
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
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Arm Title
Relamorelin 10 μg
Arm Type
Experimental
Arm Description
Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
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 subcutaneously twice daily.
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 of the previous study or the run-in period of this study for new participants.
Time Frame
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 12 of this study
Title
Change From Baseline to Week 52 in the Weekly Average DGSSS
Description
Participants assessed the severity of diabetic gastroparesis symptoms daily using the 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). The average weekly scores at Week 52 were the average of the DGSSS scores from Week 49 to Week 52. 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 study or the run-in period of this study for new participants.
Time Frame
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 52 of this study
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 56 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 participant had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Time Frame
Up to 52 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 52 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 52 weeks
Title
Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HbA1c)
Time Frame
Up to 52 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 84, Day 364, and End of Treatment (Up to Day 364)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Two different groups of participants may enter into the study:
Rollover Participants
Participants who were not randomization-eligible at the end of the Run-in Period of lead-in studies RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) are eligible to be randomized in the study if all of the following criteria apply:
•In the lead-in studies, participants must have met all screening visit and Run-in Period criteria for randomization into the Treatment Period (including compliance with dosing, entry of diary data into the Diabetic Gastroparesis Symptom Severity Diary (DGSSD)) except that:
They had zero vomiting episodes and an average daily Diabetic Gastroparesis Symptom Severity Score (DGSSS) of ≥12 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device; OR
They had vomiting episodes and an average daily DGSSS of ≥12 but <16 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device
De Novo Participants
Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) of at least 5 years' duration, with controlled and stable blood glucose levels and hemoglobin A1c (HBA1c) ≤11%
DG defined as at least a 3-month history prior to Screening of symptoms (one of which must be nausea) on an ongoing basis that are suggestive of gastroparesis (GP) (e.g., nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety)
Compliance with the entry of data into the hand-held electronic device during the Run-in Period
Compliance with administration of subcutaneous (SC) twice daily injections during the Run-in Period
The average of the daily DGSSS from the 2-week, Run-in Period must be ≥12
Exclusion Criteria:
Both Rollover and De Novo Participants
•Participants with a known allergy or hypersensitivity to the study treatments and their excipients (i.e., mannitol or phenol)
Rollover Participants
•Participants will be excluded from this study if any of the lead-in study exclusion criteria apply at the Screening Visit and at the end of the Run-in Period for randomization into the Treatment Period of studies RLM-MD-01 and RLM-MD-02, except as specified in the inclusion criteria
De Novo Participants
History of anorexia nervosa, binge-eating, bulimia, or other eating disorder within 5 years of the Screening Visit
History of intestinal malabsorption or pancreatic exocrine insufficiency
History of belching disorders, other nausea and vomiting disorders
Gastric or duodenal ulcer within 3 months of Screening
History of malignancy in the 3 years prior to Screening, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression
Use of metoclopramide, domperidone, prucalopride, macrolide antibiotics (e.g., erythromycin, clarithromycin, azithromycin), or other drugs considered to be GI promotility agents for at least 10 days prior to the start of the Run-in Period
Currently taking opiates, or expecting to use opiates during the course of the clinical study
Treatment with glucagon-like peptide-1 (GLP-1) agonist for at least 6 weeks prior to the start of the Run-in Period
History of pyloric injection of botulinum toxin within 6 months of screening
History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure (a history of diagnostic endoscopy is not exclusionary)
Randomization in any previous study in which relamorelin was a treatment
Allergic to, or intolerant of egg, wheat, milk, or algae, as these are components of the gastric emptying breath test (GEBT) study meal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harvy Schneier
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
North Alabama Research Center, LLC
City
Athens
State/Province
Alabama
ZIP/Postal Code
35611
Country
United States
Facility Name
Simon Williamson Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
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
Avant Research Associates
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Alabama Medical Group, PC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
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
85710
Country
United States
Facility Name
Del Sol Research Management, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
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
TriWest Research Associates
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
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
90057
Country
United States
Facility Name
Stanford Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Optimal Research California
City
San Diego
State/Province
California
ZIP/Postal Code
92108
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
Synexus Clinical Research US, Inc.
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
New Hope Research Development
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Synexus
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
Medical Research Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
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
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
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
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Sensible Healthcare
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
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
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
North Shore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
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
Synexus Clinical Research US, Inc.
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
66217
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
St. Elizabeth Healthcare â€" Clinical Research Institute
City
Erlanger
State/Province
Kentucky
ZIP/Postal Code
41018
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
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
Clinical Trials of America, Inc.
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
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
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
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
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, West Michigan Clinical Research Center
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
MNGI Digestive Health
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Richfield
State/Province
Minnesota
ZIP/Postal Code
55423
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
Montana Medical Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Diabetes and Endocrine Associates, P.C.
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 - CROSN
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
89135
Country
United States
Facility Name
Garden State Endocrinology LLC
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08723
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Bridgeton
State/Province
New Jersey
ZIP/Postal Code
08302
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
CHEAR Center LLC
City
Bronx
State/Province
New York
ZIP/Postal Code
10455
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
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
Carolinas Healthcare-Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
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
Synexus Clinical Research US, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
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
Synexus Clinical Research US, Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
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.
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Facility Name
Centennial Health-Synexus
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73111
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
Guthrie Clinical Research
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Frontier Clinical Research, LLC
City
Scottdale
State/Province
Pennsylvania
ZIP/Postal Code
15683
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
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
Carolina Medical Research
City
Clinton
State/Province
South Carolina
ZIP/Postal Code
29325
Country
United States
Facility Name
Gastroenterology Associates, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Synexus Clinical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
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
Gastroenterology Centers of the Midsouth
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
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
DiscoveResearch, Inc.
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
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
Amir 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
Sagact Pllc.
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
Synexus Clinical Research US, Inc.
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
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
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
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Consultorios Asociados de Endocrinologia e Investigación Cl
City
Buenos Aires
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
ZIP/Postal Code
B7600FYK
Country
Argentina
Facility Name
CIPREC
City
Buenos Aires
State/Province
Ciudad Autonoma deBuenos Aires
ZIP/Postal Code
1119
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas de Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000BIE
Country
Argentina
Facility Name
Instituto Medico Catamarca-I.ME.C
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
CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian
City
Cordoba
ZIP/Postal Code
X5000BNB
Country
Argentina
Facility Name
Centro Universitario de Investigacion en Farmacologia Clinic
City
Corrientes
ZIP/Postal Code
W3410AVV
Country
Argentina
Facility Name
Instituto Privado de Investigaciones Clinicas de Cordoba
City
Córdoba
ZIP/Postal Code
X5000AAW
Country
Argentina
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated
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
Osterreicher
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 wehlre-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
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
CE
ZIP/Postal Code
60430-270
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 Universitário João de Barros Barreto - UFPA
City
Belem
State/Province
PA
ZIP/Postal Code
66073-005
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 Clínica 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
Instituto de Estudos e Pesquisas Clinicas do Ceara IEP/CE - Oncology
City
Fortaleza
ZIP/Postal Code
60160-230
Country
Brazil
Facility Name
IPEC-Instituto de Pesquisa Clinica
City
Sao Paulo
ZIP/Postal Code
01223-001
Country
Brazil
Facility Name
CPQuali Pesquisa Clinica Ltda
City
Sao Paulo
ZIP/Postal Code
01228-000
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
Medical Center Asklepion - Humane Medicine Research EOOD
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Facility Name
Alexandrovska University Hospital
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
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
Patient research centre
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 3N2
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, Inc.
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
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
Fundación del Caribe para la InvestigacionBiomédica-Fundación 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
Endocare Ltda.
City
Bogotá
State/Province
Distrito Capital De Bogotá
ZIP/Postal Code
111111
Country
Colombia
Facility Name
Medplus Centro de Recuperacion Integral S.A.S.
City
Bogotá
State/Province
Distrito Capital
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Centro de Investigaciones Clínicas IPS CARDIOMET Pereira
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
660003
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
Steno Diabetes Center Copenhagen
City
Hellerup
State/Province
Copenhagen
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Gastroenheden, Hvidovre hospital
City
Hvidovre
State/Province
København
ZIP/Postal Code
2605
Country
Denmark
Facility Name
Klinische Forschung Karlsruhe GmbH
City
Karlsruhe
State/Province
Baden-Wurttemberg
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 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
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
Strázsahegy Gyógyszertár Medicina
City
Budapest
ZIP/Postal Code
H1171
Country
Hungary
Facility Name
Szegedi TudomanyegyetemSzent-Gyorgyi Albert Klinikai Kozpont és Altalanos Orvostudomanyi Kar Belgyogyaszati Klinika
City
Szeged
ZIP/Postal Code
H-6720
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 - Gasterentrology
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380007
Country
India
Facility Name
Zydus Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380054
Country
India
Facility Name
Lifecare Clinic and Research Centre - Internal Med/Diabetology
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
Victoria Hospital Bangalore Medical College and Research Institute
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
Facility Name
Rajalakshmi Hospital
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560097
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
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
M.V. Hospital for Diabetes & Diabetes Research Centre
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600013
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 Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Sir Ganga Ram Hospital (SGRH)
City
Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Vinaya Hospital & Research Centre
City
Mangalore
ZIP/Postal Code
575003
Country
India
Facility Name
Bnei-Zion MC
City
Haifa
ZIP/Postal Code
31948
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
Sanggye Paik Hospital, Inje University College of Medicine
City
Seoul
State/Province
Nowon-gu
ZIP/Postal Code
1757
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
Clinical Investigation Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Clinical Trial Unit, School of Medical Sciences, Health Campus, Hospital 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
Mexico DF
State/Province
Distrito Federal
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 Atención e Investigación en Factores de Riesgo Car
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14000
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 particular
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44210
Country
Mexico
Facility Name
Unidad de Investigación Clínica en Medicina S.C/
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
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
CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición)
City
Durango
ZIP/Postal Code
34270
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
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
St. Luke's Medical Center
City
Quezon City
ZIP/Postal Code
1100
Country
Philippines
Facility Name
Specjalistyczny Gabinet Neurologiczny Marta Banach
City
Kraków
State/Province
Lesser Poland
ZIP/Postal Code
30-539
Country
Poland
Facility Name
CenterMed Krakow Ltd
City
Krakow
State/Province
Malopolska
ZIP/Postal Code
31-530
Country
Poland
Facility Name
Centrum Medyczne Lukamed
City
Chojnice
ZIP/Postal Code
89-600
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
GUZ Saratov City Clinical Hospital 9
City
Saratov
State/Province
Saratov Region
ZIP/Postal Code
410030
Country
Russian Federation
Facility Name
Scientific Institute of Clinical and Experimental Lymphology
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
Rostov on Don
City
Rostov on Don
ZIP/Postal Code
344019
Country
Russian Federation
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
S169856
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 Clinical Research Centre
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0122
Country
South Africa
Facility Name
Watermeyer Clinical Research Site
City
Pretoria
State/Province
Val De Grace
ZIP/Postal Code
0184
Country
South Africa
Facility Name
Synexus Helderberg Clinical Research Centre
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Hospital Universitario Principe de Asturias
City
Madrid
ZIP/Postal Code
28850
Country
Spain
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
State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine
City
Dnipro
State/Province
Dnipropetrovs'ka Oblast'
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Municipal Institution, City Hospital #7, polyclinic department, c. Zaporizhzhia
City
Zaporizhzhia
State/Province
Zaporizhzhia Region
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Chernivtsi Regional Clinical Hospital
City
Chernivtsi
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Regional Municipal noncommercial Enterprise "Chernivtsi Regional Endocrinology Center", Polyclinic department, Higher State Educational Establishment of Ukraine "Bukovinian State Medical University", Department of Clinical Immunology, Allergology and Endo
City
Chernivtsi
ZIP/Postal Code
58022
Country
Ukraine
Facility Name
Ivano-Frankivsk National Medical University
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Ivano-Frankivsk Central City Clinical Hospital
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Municipal nonprofit entity of Kharkiv municipal council
City
Kharkiv
ZIP/Postal Code
61037
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
Kyiv Railway Clinical Hospital No-2 of Branch of Healthcare Center of the PJSC Ukrainian Railway , Endocrynology Department
City
Kyiv
ZIP/Postal Code
3049
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
Poltava Regional Clinical Hospital
City
Poltava
ZIP/Postal Code
36011
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 Institution 6th City Clinical Hospital, Dept of Gastroenterology
City
Zaporizhzhia
ZIP/Postal Code
69035
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 Clinical Research
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L34 1BH
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
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, GAC House
City
Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04
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