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Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis

Primary Purpose

Diabetes Mellitus, Diabetes Mellitus Complications, Gastroparesis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Relamorelin
Placebo
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, Delayed Gastric Emptying, Vomiting, Gastroparesis, Gastrointestinal Motility Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM) with stable glycemic control and Hemoglobin A1c (HbA1c) ≤11% at screening.
  • Diabetic gastroparesis (DG), defined as at least a 3-month history of symptoms suggestive of gastroparesis on an ongoing basis (e.g., vomiting, nausea, early satiety, bloating, or epigastric or abdominal pain).
  • Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) score ≥2.6 at least once during the Screening Period (Visits 1-2).
  • At least 2 vomiting episodes during the ~2 weeks prior to the first screening visit (Visit 1), as ascertained by patient history.
  • Delayed Gastric Emptying (GE) confirmed at screening by abnormal Gastric Emptying Breath Test (GEBT), defined as GE half-time (t1/2) ≥79 minutes (the 80th percentile of normative data). At least 50% of patients enrolled will have a t1/2 ≥97 minutes (i.e., the 95th percentile).
  • Stable concomitant medications, defined as no changes in regimen for at least 2 weeks prior to Visit 2 (daily adjustments of insulin doses are permitted).
  • No use of metoclopramide, erythromycin, domperidone, or other gastrointestinal (GI) motility agents, or anti-emetics for at least 2 weeks prior to Visit 2, and willingness to remain off these medications (except as used as part of protocol-specific rescue medication) during the course of the clinical trial.
  • Body mass index >18 kg/m2.
  • If female, has a negative serum or urine pregnancy test and is not lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. Female patients unable to bear children must have this documented in the electronic case report form (eCRF) (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of 1 year since the last menstrual period]). Post-menopausal status will be confirmed by measurement of follicle stimulating hormone (FSH).
  • Able to provide written informed consent prior to any study procedures and willing and able to comply with study procedures.

Additional inclusion criteria for randomization after the 2-week single-blind placebo run-in period:

  • Compliance with the completion of the Diabetic Gastroparesis Symptom Severity Diary (DGSSD) and study drug injections, defined as approximately 80% diary completions and approximately 80% administration of injections, during the 2-week single-blind placebo run-in period. For those patients whose compliance is measured to be <80%, the final decision to randomize a patient will be made by the Investigator and the Sponsor (or designee).
  • At least one vomiting episode at any time during the 2-week single-blind placebo run-in period, as recorded in the DGSSD.

Exclusion Criteria:

  • Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube [e.g., Percutaneous Endoscopic Gastrostomy (PEG) tube] for feeding or decompression.
  • History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure. (A history of diagnostic endoscopy is not exclusionary.)
  • History of pyloric injection of botulinum toxin within 6 months of screening.
  • Patients with clinical suspicion of upper GI obstruction (e.g., peptic stricture) must have been evaluated per standard of care and obstruction ruled out before screening.
  • Currently taking opiates, or expecting to use opiates during the course of the clinical trial.
  • Currently taking Glucagon-like peptide-1 (GLP-1) agonists, Sodium-glucose co-transporter 2 (SGLT2) inhibitors or pramlintide.
  • Allergic or intolerant of egg, wheat, milk, or algae, as these are components of the Gastric emptying breath test (GEBT) study meal. (Gluten-free crackers can be provided.)
  • History of anorexia nervosa, binge-eating, or bulimia within 5 years of screening.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × upper limit of normal (ULN) at Visit 1.
  • History of intestinal malabsorption or pancreatic exocrine disease.
  • Requires hemodialysis or has end-stage renal disease.
  • History of human immunodeficiency virus (HIV) infection.
  • Clinically significant neurologic or psychiatric disorders that are likely to impact compliance with protocol requirements.
  • Poor venous access or inability to tolerate venipuncture.
  • Participation in a clinical study within the 30 days prior to dosing in the present study.
  • Any other reason that, in the Investigator's opinion, would confound proper interpretation of the study or expose a patient to unacceptable risk, including renal, hepatic or cardiopulmonary disease, or significant acute electrocardiogram (ECG) abnormalities.

Sites / Locations

  • Digestive Health Specialist of the Southeast
  • Desert Sun Clinical Research
  • Adobe Clinical Research
  • Harrisburg Family Medical Center
  • Arkansas Primary Care Clinic
  • Preferred Research Partners, Inc.
  • TriWest Research Associates
  • Torrance Clinical Research Institute Inc.
  • Axis Clinical Trials
  • Inland Empire Liver Foundation
  • Syrentis Clinical Research
  • Ventura Clinical Trials
  • Danbury Hospital- Office of Clinical trials
  • Avail Clinical Research
  • International Research Associates LLC
  • Nature Coast Clinical Research
  • APF Research, LLC
  • Advanced Pharma CR, LLC
  • Baptist Diabetes Associates, P.A.
  • International Research Associates LLC
  • Advanced Research Institute Inc
  • Advanced Medical Research Center
  • Palm Beach Research Center
  • River Birch Research Alliance LLC
  • Rockford Gastroenterology Associates, Ltd.
  • Medisphere Medical Research Center
  • Professional Research Network of Kansas, LLC
  • University of Louisville
  • Delta Research Partners
  • Clinical Trials of America LA, LLC
  • Metropolitan Gastroenterology Group, P.C. (Chevy Chase Clinical Research) Chevy Chase Clinical Research
  • Beth Israel Deaconess Medical Center
  • Clinical Research Institute of Michigan, LLC
  • Detroit Clinical Research Center, PC-Farmington Hills
  • Center For Digestive Health
  • Mayo Clinic
  • Planters Clinic
  • Impact Clinical Trials
  • Advanced Biomedical Research of America
  • New York Clinical Trials, Inc
  • Cumberland Research Associates, LLC
  • OnSite Clinical Solutions- Lexington OnSite Clinical Solutions, LLC
  • Diabetes and Endocrinology Consultants, P.C.
  • OnSite Clinical Solutions, LLC
  • Trial Management Associates, LLC
  • Wake Forest University Baptist Health - Dept of Gastroenterology Medical Center Blvd
  • Consultants for Clinical Research
  • Prestige Clinical Research
  • MetroHealth Medical Center
  • Great Lakes Gastroenterology Research
  • Northwest Gastroenterology Clinic
  • Family Medicine of SayeBrook
  • ClinSearch LLC
  • GI Specialists of Houston
  • Houston Methodist Hospital
  • The University of Texas Health Science Center & Medical School at Houston
  • Texas Tech University Health Sciences Center
  • Gulf Coast Medical Research, LLC
  • Aspen Clinical Research
  • Highland Clinical Research
  • Gastroenterology Associates of Tidewater
  • Khan and Abbasi Research
  • Healing Hands of Virginia LLC
  • Gastroenterology Consultants
  • ZainResearch, LLC
  • Hopital Erasme - Universite Libre de Bruxelles
  • UZ Leuven
  • Herz und Diabeteszentrum Nordrhein Westfalen, Universitätsklinikum der Ruhr-Universiät Bochum
  • Praxis Dr. Ott Rabenauer Str.
  • GWT-TUD GmbH
  • Israelitisches Krankenhaus Orchideenstig
  • Diabetes Zentrum und Praxis Prof. Pfützner Parcusstr.
  • Rambam Health Care Campus - Inst. of Endocrinology, Diabetes, and Metabolism
  • Wolfson Medical Center
  • Rabin Medical Center, Beilinson Hospital Gastroenterology Dept
  • ZIV Medical Center
  • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorób Kostno-Stawowych J. Badurski S.J. ul.
  • NZOZ Witamed al.
  • CenterMed Krakow
  • Gabinet Lekarski dr n.med. Malgorzata Saryusz-Wolska ul.
  • NZOZ Pulsmedica ul.
  • KO-MED Centra Kliniczne
  • Centrum Badawcze Wspólczesnej Terapii ul.
  • Gastroenterology Karolinska University Hospital Karolinska Universitetssjukhuset Gastro Centrum Medicine
  • Uppsala University Hospital Gastroenterology / Mag-Tarmmottagningen ingang
  • NHS Tayside
  • Wansbeck General Hospital (Northumbria NHS Trust)
  • University Hospital of North Durham University Hospital of North Durham Research and Development Directorate
  • Royal Liverpool University Hospital
  • King's College Hospital
  • The James Cook University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Relamorelin 10 μg

Relamorelin 30 μg

Relamorelin 100 μg

Placebo

Arm Description

Relamorelin 10 microgram (μg) was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.

Relamorelin 30 μg was administered SC by injection BID for 12 weeks.

Relamorelin 100 μg was administered SC by injection BID for 12 weeks.

Placebo-matching relamorelin was administered SC by injection BID for 12 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline to Week 12 in Weekly Vomiting Episodes
Vomiting episodes were assessed via the Diabetic Gastroparesis Symptoms Severity Diary (DGSSD). The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of Diabetic Gastroparesis (DG) (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Each day, the participant recorded the number of vomiting episodes in the past 24 hours in the diary. Higher scores indicate more vomiting episodes. Weekly scores were averaged across the 12 weeks period. A negative change from Baseline indicates improvement.

Secondary Outcome Measures

Change From Baseline to Week 12 in Weekly DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal Pain)
The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of DG (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Severity of nausea, bloating and abdominal pain, were assessed on a numerical rating scale of 0 to 10, with 0 equating to "no" (symptom) and 10 equating to "worst possible" (symptom). Early satiety was assessed on a 5-item scale with 1 being "Only 1 or 2 bites" and 5 being "All of a normal-sized meal"; symptom severity scores for this item were reversed and normalized to a range 0 to 10 for the development of the DGSSD 4-symptom Composite Score. The DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal pain) range is 0 to 40. Higher scores indicate worse condition. Weekly scores were averaged across 12 weeks period. A negative change from Baseline indicates improvement.
Change From Baseline to Week 12 for Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-time
GE was measured via the GEBT and was reported as a time to half (t1/2) of the theoretical total GE. GEBT is a non-radioactive stable isotope breath test intended for measurement of GE of solids in participants. A negative change from Baseline indicates improvement.

Full Information

First Posted
January 29, 2015
Last Updated
July 1, 2019
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02357420
Brief Title
Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis
Official Title
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 29, 2015 (Actual)
Primary Completion Date
June 9, 2016 (Actual)
Study Completion Date
June 9, 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effects of multiple dose regimens of relamorelin on vomiting episodes, gastric emptying and gastroparesis symptoms in participants with Type 1 and Type 2 diabetes mellitus and gastroparesis. Study drug (relamorelin and placebo) will be administered subcutaneously in a blinded fashion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetes Mellitus Complications, Gastroparesis
Keywords
Diabetes Mellitus, Delayed Gastric Emptying, Vomiting, Gastroparesis, Gastrointestinal Motility Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
393 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relamorelin 10 μg
Arm Type
Experimental
Arm Description
Relamorelin 10 microgram (μg) was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.
Arm Title
Relamorelin 30 μg
Arm Type
Experimental
Arm Description
Relamorelin 30 μg was administered SC by injection BID for 12 weeks.
Arm Title
Relamorelin 100 μg
Arm Type
Experimental
Arm Description
Relamorelin 100 μg was administered SC by injection BID for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo-matching relamorelin was administered SC by injection BID for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Relamorelin
Other Intervention Name(s)
RM-131
Intervention Description
Double blind relamorelin was given subcutaneously BID for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo given subcutaneously for 12 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline to Week 12 in Weekly Vomiting Episodes
Description
Vomiting episodes were assessed via the Diabetic Gastroparesis Symptoms Severity Diary (DGSSD). The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of Diabetic Gastroparesis (DG) (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Each day, the participant recorded the number of vomiting episodes in the past 24 hours in the diary. Higher scores indicate more vomiting episodes. Weekly scores were averaged across the 12 weeks period. A negative change from Baseline indicates improvement.
Time Frame
7 days prior to Day 1 for Baseline to 7 days prior to Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 12 in Weekly DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal Pain)
Description
The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of DG (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Severity of nausea, bloating and abdominal pain, were assessed on a numerical rating scale of 0 to 10, with 0 equating to "no" (symptom) and 10 equating to "worst possible" (symptom). Early satiety was assessed on a 5-item scale with 1 being "Only 1 or 2 bites" and 5 being "All of a normal-sized meal"; symptom severity scores for this item were reversed and normalized to a range 0 to 10 for the development of the DGSSD 4-symptom Composite Score. The DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal pain) range is 0 to 40. Higher scores indicate worse condition. Weekly scores were averaged across 12 weeks period. A negative change from Baseline indicates improvement.
Time Frame
7 days prior to Day 1 for Baseline to 7 days prior to Week 12
Title
Change From Baseline to Week 12 for Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-time
Description
GE was measured via the GEBT and was reported as a time to half (t1/2) of the theoretical total GE. GEBT is a non-radioactive stable isotope breath test intended for measurement of GE of solids in participants. A negative change from Baseline indicates improvement.
Time Frame
Baseline (Day 1) to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM) with stable glycemic control and Hemoglobin A1c (HbA1c) ≤11% at screening. Diabetic gastroparesis (DG), defined as at least a 3-month history of symptoms suggestive of gastroparesis on an ongoing basis (e.g., vomiting, nausea, early satiety, bloating, or epigastric or abdominal pain). Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) score ≥2.6 at least once during the Screening Period (Visits 1-2). At least 2 vomiting episodes during the ~2 weeks prior to the first screening visit (Visit 1), as ascertained by patient history. Delayed Gastric Emptying (GE) confirmed at screening by abnormal Gastric Emptying Breath Test (GEBT), defined as GE half-time (t1/2) ≥79 minutes (the 80th percentile of normative data). At least 50% of patients enrolled will have a t1/2 ≥97 minutes (i.e., the 95th percentile). Stable concomitant medications, defined as no changes in regimen for at least 2 weeks prior to Visit 2 (daily adjustments of insulin doses are permitted). No use of metoclopramide, erythromycin, domperidone, or other gastrointestinal (GI) motility agents, or anti-emetics for at least 2 weeks prior to Visit 2, and willingness to remain off these medications (except as used as part of protocol-specific rescue medication) during the course of the clinical trial. Body mass index >18 kg/m2. If female, has a negative serum or urine pregnancy test and is not lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. Female patients unable to bear children must have this documented in the electronic case report form (eCRF) (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of 1 year since the last menstrual period]). Post-menopausal status will be confirmed by measurement of follicle stimulating hormone (FSH). Able to provide written informed consent prior to any study procedures and willing and able to comply with study procedures. Additional inclusion criteria for randomization after the 2-week single-blind placebo run-in period: Compliance with the completion of the Diabetic Gastroparesis Symptom Severity Diary (DGSSD) and study drug injections, defined as approximately 80% diary completions and approximately 80% administration of injections, during the 2-week single-blind placebo run-in period. For those patients whose compliance is measured to be <80%, the final decision to randomize a patient will be made by the Investigator and the Sponsor (or designee). At least one vomiting episode at any time during the 2-week single-blind placebo run-in period, as recorded in the DGSSD. Exclusion Criteria: Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube [e.g., Percutaneous Endoscopic Gastrostomy (PEG) tube] for feeding or decompression. History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure. (A history of diagnostic endoscopy is not exclusionary.) History of pyloric injection of botulinum toxin within 6 months of screening. Patients with clinical suspicion of upper GI obstruction (e.g., peptic stricture) must have been evaluated per standard of care and obstruction ruled out before screening. Currently taking opiates, or expecting to use opiates during the course of the clinical trial. Currently taking Glucagon-like peptide-1 (GLP-1) agonists, Sodium-glucose co-transporter 2 (SGLT2) inhibitors or pramlintide. Allergic or intolerant of egg, wheat, milk, or algae, as these are components of the Gastric emptying breath test (GEBT) study meal. (Gluten-free crackers can be provided.) History of anorexia nervosa, binge-eating, or bulimia within 5 years of screening. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × upper limit of normal (ULN) at Visit 1. History of intestinal malabsorption or pancreatic exocrine disease. Requires hemodialysis or has end-stage renal disease. History of human immunodeficiency virus (HIV) infection. Clinically significant neurologic or psychiatric disorders that are likely to impact compliance with protocol requirements. Poor venous access or inability to tolerate venipuncture. Participation in a clinical study within the 30 days prior to dosing in the present study. Any other reason that, in the Investigator's opinion, would confound proper interpretation of the study or expose a patient to unacceptable risk, including renal, hepatic or cardiopulmonary disease, or significant acute electrocardiogram (ECG) abnormalities.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wieslaw Bochenek, MD
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Digestive Health Specialist of the Southeast
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Desert Sun Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Adobe Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Harrisburg Family Medical Center
City
Harrisburg
State/Province
Arkansas
ZIP/Postal Code
72432
Country
United States
Facility Name
Arkansas Primary Care Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
Preferred Research Partners, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
TriWest Research Associates
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Torrance Clinical Research Institute Inc.
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Syrentis Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Ventura Clinical Trials
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Danbury Hospital- Office of Clinical trials
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Avail Clinical Research
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
International Research Associates LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
APF Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Advanced Pharma CR, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Baptist Diabetes Associates, P.A.
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
International Research Associates LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Advanced Research Institute Inc
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Advanced Medical Research Center
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
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
Rockford Gastroenterology Associates, Ltd.
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Medisphere Medical Research Center
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Professional Research Network of Kansas, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Delta Research Partners
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Clinical Trials of America LA, LLC
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Facility Name
Metropolitan Gastroenterology Group, P.C. (Chevy Chase Clinical Research) Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Detroit Clinical Research Center, PC-Farmington Hills
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Center For Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Planters Clinic
City
Port Gibson
State/Province
Mississippi
ZIP/Postal Code
39150
Country
United States
Facility Name
Impact Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Advanced Biomedical Research of America
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
New York Clinical Trials, Inc
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Facility Name
Cumberland Research Associates, LLC
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
OnSite Clinical Solutions- Lexington OnSite Clinical Solutions, LLC
City
Lexington
State/Province
North Carolina
ZIP/Postal Code
27292
Country
United States
Facility Name
Diabetes and Endocrinology Consultants, P.C.
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
OnSite Clinical Solutions, LLC
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
Trial Management Associates, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Wake Forest University Baptist Health - Dept of Gastroenterology Medical Center Blvd
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27107
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
MetroHealth Medical Center
City
Leveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Great Lakes Gastroenterology Research
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Northwest Gastroenterology Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Family Medicine of SayeBrook
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29588
Country
United States
Facility Name
ClinSearch LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
GI Specialists of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77015
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Health Science Center & Medical School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
Gulf Coast Medical Research, LLC
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Aspen Clinical Research
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Highland Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Gastroenterology Associates of Tidewater
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Khan and Abbasi Research
City
Chester
State/Province
Virginia
ZIP/Postal Code
23831
Country
United States
Facility Name
Healing Hands of Virginia LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Gastroenterology Consultants
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23455
Country
United States
Facility Name
ZainResearch, LLC
City
Richland
State/Province
Washington
ZIP/Postal Code
99352
Country
United States
Facility Name
Hopital Erasme - Universite Libre de Bruxelles
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Herz und Diabeteszentrum Nordrhein Westfalen, Universitätsklinikum der Ruhr-Universiät Bochum
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Praxis Dr. Ott Rabenauer Str.
City
Dippoldiswalde
ZIP/Postal Code
01744
Country
Germany
Facility Name
GWT-TUD GmbH
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Israelitisches Krankenhaus Orchideenstig
City
Hamburg
ZIP/Postal Code
22297
Country
Germany
Facility Name
Diabetes Zentrum und Praxis Prof. Pfützner Parcusstr.
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
Rambam Health Care Campus - Inst. of Endocrinology, Diabetes, and Metabolism
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Rabin Medical Center, Beilinson Hospital Gastroenterology Dept
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
ZIV Medical Center
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorób Kostno-Stawowych J. Badurski S.J. ul.
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
NZOZ Witamed al.
City
Kielce
ZIP/Postal Code
25-035
Country
Poland
Facility Name
CenterMed Krakow
City
Krakow
ZIP/Postal Code
31530
Country
Poland
Facility Name
Gabinet Lekarski dr n.med. Malgorzata Saryusz-Wolska ul.
City
Lodz
ZIP/Postal Code
90-132
Country
Poland
Facility Name
NZOZ Pulsmedica ul.
City
Lodz
ZIP/Postal Code
93-509
Country
Poland
Facility Name
KO-MED Centra Kliniczne
City
Staszów
ZIP/Postal Code
28-200
Country
Poland
Facility Name
Centrum Badawcze Wspólczesnej Terapii ul.
City
Warszawa
ZIP/Postal Code
02-679
Country
Poland
City
Warszawa
ZIP/Postal Code
02-679
Country
Poland
Facility Name
Gastroenterology Karolinska University Hospital Karolinska Universitetssjukhuset Gastro Centrum Medicine
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Uppsala University Hospital Gastroenterology / Mag-Tarmmottagningen ingang
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
Facility Name
NHS Tayside
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Wansbeck General Hospital (Northumbria NHS Trust)
City
Ashington
ZIP/Postal Code
NE63 9JJ
Country
United Kingdom
Facility Name
University Hospital of North Durham University Hospital of North Durham Research and Development Directorate
City
Durham
ZIP/Postal Code
DH1 5TW
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
The James Cook University Hospital
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
City
Tyne And Wear
ZIP/Postal Code
NE29 8NH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32301137
Citation
Camilleri M, Lembo A, McCallum R, Tourkodimitris S, Kemps L, Miller MB, Bertelsen K, Iacob A. Overall safety of relamorelin in adults with diabetic gastroparesis: Analysis of phase 2a and 2b trial data. Aliment Pharmacol Ther. 2020 Jun;51(11):1139-1148. doi: 10.1111/apt.15711. Epub 2020 Apr 17.
Results Reference
derived
PubMed Identifier
28760384
Citation
Camilleri M, McCallum RW, Tack J, Spence SC, Gottesdiener K, Fiedorek FT. Efficacy and Safety of Relamorelin in Diabetics With Symptoms of Gastroparesis: A Randomized, Placebo-Controlled Study. Gastroenterology. 2017 Nov;153(5):1240-1250.e2. doi: 10.1053/j.gastro.2017.07.035. Epub 2017 Jul 29.
Results Reference
derived

Learn more about this trial

Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis

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