Summary

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

Description

Summary

This open-label study is to assess the safety of continued treatment with Relamorelin for participants who previously completed the RLM-MD-03 or RLM-MD-04 study and to provide treatment for these participants until Relamorelin becomes commercially available or the Sponsor terminates development.

Official Title

Open-label Extension Study of Relamorelin for the Treatment of Diabetic Gastroparesis

Keywords

Gastroparesis Diabetic Gastroparesis Relamorelin 10 μg

Eligibility

You can join if…

Open to people ages 18 years and up

  • Successful completion of either Study RLM-MD-03 or Study RLM-MD-04
  • Ability to provide written IC prior to any study procedures and willingness and ability to comply with study procedures
  • Demonstration of adequate compliance with the study procedures in Study RLM-MD-03 or RLM-MD-04, in the opinion of the investigator

You CAN'T join if...

  • Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study 3071-305-020.
  • Participant has an unresolved AE from a lead-in study, ie, a clinically significant finding on physical examination, clinical laboratory test, or 12-lead 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
  • Females who are pregnant, nursing, or planning a pregnancy during the study

Locations

  • University of California San Diego not yet accepting patients
    La Jolla California 92037 United States
  • Medical Associates Research Group, Inc not yet accepting patients
    San Diego California 92123 United States
  • Clinical Applications Laboratories, Inc. not yet accepting patients
    San Diego California 92103 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Allergan
ID
NCT03786380
Phase
Phase 3
Study Type
Interventional
Last Updated