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

Purpose

Extension study for RLM-MD-02 participants. To compare the efficacy of relamorelin with placebo in participants after 12 weeks of treatment. Total of 24 weeks (12 weeks from RLM-MD-02 study and 12 weeks from this study)

Criteria

Participant met all inclusion/exclusion criteria in RLM-MD-02 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

You Cannot:

Be planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03

Have an unresolved AE or 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

Details

Study Duration: 46 weeks



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IRB: Copernicus
IRB Number:
Trial Type: Drug
Sponsor: Allergan