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

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

NCT03426345

Run by

Allergan

People needed

311

Starts

2018-02-16

Expected to finish

2020-07-16

Last updated by the study team

2021-08-06

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

• Synexus Clinical Research US - Simon Williamson Clinic — Birmingham, Alabama, United States
• G & L Research, LLC — Foley, Alabama, United States
• Alabama Medical Group, PC — Mobile, Alabama, United States
• Synexus Clinical Research US, Inc. — Tucson, Arizona, United States
• Applied Research Center of Arkansas — Little Rock, Arkansas, United States
• Unity Health - Searcy Medical Center — Searcy, Arkansas, United States
• GW Research Inc. — Chula Vista, California, United States
• Diagnamics Inc. — Encinitas, California, United States
• Fresno Clinical Research Center — Fresno, California, United States
• Torrance Clinical Research Institute, Inc. — Lomita, California, United States
• Tibor Rubin VA Medical Center — Long Beach, California, United States
• Angel City Research Inc. — Los Angeles, California, United States
• Facey Medical Foundation — Mission Hills, California, United States
• United Medical Doctors — Murrieta, California, United States
• Stanford Hospital, Digestive Health Clinic — Palo Alto, California, United States
• TriWest Research Associates — Poway, California, United States
• Optimal Research California — San Diego, California, United States
• Syrentis Clinical Research — Santa Ana, California, United States
• New Hope Research Development — Whittier, California, United States
• Synexus Clinical Research US, Inc. - Colorado Springs Family Practice — Colorado Springs, Colorado, United States
• Gastroenterology Associates of Fairfield County, P.C. — Bridgeport, Connecticut, United States
• Visionary Investigators Network — Aventura, Florida, United States
• Clinical Research of West Florida — Clearwater, Florida, United States
• ALL Medical Research LLC — Cooper City, Florida, United States
• North Alabama Research Center, LLC — Athens, Alabama, United States

Full record on ClinicalTrials.gov

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