A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Gastroparesis, Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT03285308

Run by

Allergan

People needed

336

Starts

2017-09-29

Expected to finish

2020-07-08

Last updated by the study team

2021-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Digestive Health Specialist of the South East — Dothan, Alabama, United States
• Avant Research Associates — Huntsville, Alabama, United States
• Synexus Clinical Research US, Inc. — Fountain Hills, Arizona, United States
• Central Arizona Medical Associates — Mesa, Arizona, United States
• Phoenix Clinical LLC — Phoenix, Arizona, United States
• Del Sol Research Management, LLC — Tucson, Arizona, United States
• Preferred Research Partners, Inc. — Little Rock, Arkansas, United States
• Arkansas Gastorenterology — North Little Rock, Arkansas, United States
• Hope Clinical Research — Canoga Park, California, United States
• Kindred Medical Institute for Clinical Trials, LLC — Corona, California, United States
• Aurora Care Clinic, LLC — Costa Mesa, California, United States
• Citrus Valley Gastroenterology Clinic — Covina, California, United States
• VVCRD Research — Garden Grove, California, United States
• University of California San Diego — La Jolla, California, United States
• Om Research LLC — Lancaster, California, United States
• Clinical Applications Laboratories, Inc. — San Diego, California, United States
• Medical Associates Research Group, Inc — San Diego, California, United States
• Synexus Clinical Research, US, Santa Rosa — Santa Rosa, California, United States
• Upland Clinical Research — Upland, California, United States
• Synexus Clinical Research US, Inc. — Vista, California, United States
• University of Colorado, Denver — Aurora, Colorado, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Denver Esophageal and Stomach Center — Englewood, Colorado, United States
• Connecticut Clinical Research Foundation — Bristol, Connecticut, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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