Overview

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