Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

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.

Official Title

A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

Keywords

Gastroparesis Diabetes Mellitus diabetic gastroparesis vomiting Relamorelin Relamorelin 10 μg

Eligibility

You can join if…

Open to people ages 18 years and up

  • Participants are eligible to be included in the study only if all the following criteria apply:
  • Participant met all inclusion/

You CAN'T join if...

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

Locations

  • University of California San Diego
    La Jolla California 92037 United States
  • Medical Associates Research Group, Inc
    San Diego California 92123 United States
  • Clinical Applications Laboratories, Inc.
    San Diego California 92103 United States
  • Diagnamics Inc.
    Encinitas California 92024 United States
  • TriWest Research Associates
    El Cajon California 92020 United States
  • GW Research Inc
    Chula Vista California 91910 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Allergan
ID
NCT03420781
Phase
Phase 3
Study Type
Interventional
Last Updated
May 14, 2018