A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis

Purpose

To compare the efficacy of relamorelin with that of placebo in participants with DG with respect to a composite of the following core signs and symptoms of DG:

Nausea

Abdominal Pain

Postprandial fullness

Bloating

Criteria

Study Population: Two different groups of participants may enter the study:

Participants who met all Screening and Run-in Period criteria in lead-in Study RLM-MD-02 (including compliance with dosing and data entry into the Diabetic Gastroparesis Symptom Severity Diary [DGSSD] during the lead-in study Run-in Period), but were not randomization-eligible at the end of the lead-in study Run-in Period, are eligible for randomization in Study RLM-MD-04 if:

They had no vomiting episodes recorded in the DGSSD and had an average daily DGSSS ≥ 12 at the end of the lead-in study Run-in Period. OR

They had vomiting episodes recorded in the DGSSD but had an average daily DGSSS of ≥ 12 and  < 16 at the end of the lead-in study Run-in Period.

Details

Study Duration: 52 weeks



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