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

• Status: Terminated
• Trial end date: 2020-10-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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