Summary

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

Description

Summary

A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.

Official Title

A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study 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 of the following criteria apply:
  • Participants must meet all the inclusion criteria at screening (Visit 1) and at the end of the Run-in Period (Visit 3) for randomization into the Treatment Period of RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) (including compliance with dosing,entry of diary data into the DGSSD except:
  • 1) Participants are not required to have at least 1 vomiting episode recorded in the DGSSD using the electronic hand-held device during the Run-in Period. For entry into RLM-MD-04, the number of vomiting episodes must be 0; and/or
  • 2) Participants are not required to have an average of daily DGSSS at the end of the Run-in Period of≥16, but it must be ≥12.

You CAN'T join if...

  • There are no exclusion criteria specific to this study; participants will be excluded from this study if any of the exclusion criteria apply at screening (Visit 1) and at the end of the Run-in Period (Visit 3) for randomization into the Treatment Period of studies RLM-MD-01 and RLM-MD-02, except as specified in the inclusion criteria

Locations

  • University of California San Diego not yet accepting patients
    La Jolla California 92037 United States
  • Medical Associates Research Group, Inc accepting new patients
    San Diego California 92123 United States
  • Clinical Applications Laboratories, Inc. not yet accepting patients
    San Diego California 92103 United States
  • Diagnamics Inc. accepting new patients
    Encinitas California 92024 United States
  • TriWest Research Associates accepting new patients
    El Cajon California 92020 United States
  • GW Research Inc accepting new patients
    Chula Vista California 91910 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Allergan
Links
Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR‐CTRegistration@Allergan.com for assistance.
ID
NCT03383146
Phase
Phase 3
Study Type
Interventional
Last Updated
May 17, 2018