Diabetic Gastroparesis Study 4
Research type
Research Study
Full 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
IRAS ID
247565
Contact name
Catherine Carter
Contact email
Sponsor organisation
Allergan Ltd.
Eudract number
2017-002144-33
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
108,970, IND
Duration of Study in the UK
2 years, 1 months, 25 days
Research summary
The purpose of this study is to look into the 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. One cause of gastroparesis is long-standing diabetes. 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 determine if Relamorelin can help reduce vomiting episodes and associated symptoms (bloating, nausea, stomach pain and feeling full) in people with diabetic gastroparesis.
This research study is looking for approximately 600 participants with diabetic gastroparesis. The study will be done at approximately 400 study sites across the world.
Participants who choose to be a part of this study will be assigned by chance (like flipping a coin) to one of the following study groups:
• 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
There is approximately a 66% chance participants will be assigned to receive Relamorelin, and a 33% chance they will receive placebo during the treatment period.
Participants will attend between seven (Rollover study) and nine (DeNovo study) study visits over a period of approximately 52 (Rollover study) or 56 (DeNovo study) weeks.
The study will be run at hospitals and private health clinics.REC name
London - City & East Research Ethics Committee
REC reference
18/LO/1399
Date of REC Opinion
31 Oct 2018
REC opinion
Further Information Favourable Opinion