Diabetic Gastroparesis Study with Randomized-withdrawal Period
Research type
Research Study
Full title
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
IRAS ID
247563
Contact name
Catherine Carter
Contact email
Sponsor organisation
Allergan Ltd.
Eudract number
2017-002143-15
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
108,970, IND
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
The purpose of this study is to look into the long-term safety and efficacy of a study drug called Relamorelin in the treatment of diabetic gastroparesis.
Gastroparesis is a condition where the stomach does not empty properly. In a healthy stomach, the muscles push food through the digestive system. Gastroparesis is when the stomach muscles fail to empty the stomach normally. This condition can lead to poor nutrition, difficulty with digestion and symptoms like nausea and vomiting. Gastroparesis is often found in people with diabetes. In the EU there are currently no medications approved specifically for the treatment of diabetic gastroparesis.
This study will compare Relamorelin with a placebo (a placebo is an inactive solution that looks like Relamorelin, but does not contain Relamorelin) to see if taking relamorelin is better at improving the participants symptoms of diabetic gastroparesis than taking a placebo.
This research study is looking for approximately 960 participants with diabetic gastroparesis who have successfully completed the lead-in study RLM-MD-02. The study will be done at approximately 400 study centres across the world.
Once participants have completed the lead-in study (RLM-MD-02) and met the entry criteria for this study, they will continue to receive the same study drug for the first 40 weeks (after which the study drug may change for the last 6 weeks of the study); either Relamorelin or placebo depending on what they received in the lead-in study as described below:
• Relamorelin - 10 μg of study drug in a Pre-Filled Cartridge in a Multidose Pen Injector for injection under the skin
• Placebo – no study drug in a Pre-Filled Cartridge in a Multidose Pen Injector for injection under the skin
Participants will attend a total of eight (8) study visits over a period of approximately 46 weeks.
The study will be run at hospitals and private health clinics.REC name
London - City & East Research Ethics Committee
REC reference
18/LO/1398
Date of REC Opinion
31 Oct 2018
REC opinion
Further Information Favourable Opinion