Study 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
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
Eligibility
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.
Study Process
Study Duration: 52 weeks
Interested in more information on clinical research? Contact WK Physician Network Clinical Research at 318-212-8613
Trial Details
Investigator:
IRB:
Copernicus
IRB Number:
Trial Type:
Drug
Sponsor:
Allergan
Contact Information: