A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Gastroparesis, Diabetes Mellitus

In brief

A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.

Key facts

Study ID

NCT03420781

Run by

Allergan

People needed

467

Starts

2018-01-24

Expected to finish

2020-10-30

Last updated by the study team

2021-12-22

Who can join

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

You may qualify if…

• Participants are eligible to be included in the study only if all the following criteria apply:
• Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study
• Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures
• In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02

You may not qualify if…

• Participants are excluded from the study if any of the following criteria apply:
• Participant is not willing or able to abide by the restrictions regarding concomitant medicine use
• Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03
• Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study
• Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease

Where it is running

• Digestive Health Specialist of the South East — Dothan, Alabama, United States
• G & L Research, LLC — Foley, Alabama, United States
• Alabama Medical Group, PC — Mobile, Alabama, United States
• Del Sol Research Management, LLC — Chandler, 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
• Applied Research Center of Arkansas — Little Rock, Arkansas, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States
• Unity Health - Searcy Medical Center — Searcy, Arkansas, United States
• Hope Clinical Research — Canoga Park, California, United States
• GW Research Inc — Chula Vista, California, United States
• Kindred Medical Institute for Clinical Trials, LLC — Corona, California, United States
• Aurora Care Clinic, LLC — Costa Mesa, California, United States
• Diagnamics Inc. — Encinitas, 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
• Torrance Clinical Research Institute, Inc. — Lomita, California, United States
• Angel City Research Inc. — Los Angeles, California, United States
• TriWest Research Associates — Poway, California, United States
• Medical Associates Research Group, Inc — San Diego, California, United States
• Syrentis Clinical Research — Santa Ana, California, United States
• Upland Clinical Research — Upland, California, United States
• North Alabama Research Center, LLC — Athens, Alabama, United States

Full record on ClinicalTrials.gov

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