Diabetic Gastroparesis Study 2

• Research type

  Research Study

• Full title

  A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis

• IRAS ID

  247266

• Contact name

  Catherine Carter

• Contact email

  Catherine.Carter@PAREXEL.com

• Sponsor organisation

  Allergan Ltd.

• Eudract number

  2017-002177-20

• Clinicaltrials.gov Identifier

  NCT03426345

• Duration of Study in the UK

  1 years, 4 months, 1 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. 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 study is looking for approximately 600 participants with diabetic gastroparesis and will be done at approximately 200 study sites across the world. Patients who fit the inclusion and exclusion criteria and have diabetic gastroparesis may be invited.
  
  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 50% chance that they will be assigned to receive placebo or Relamorelin during the treatment period. There will be a total of seven (7) study visits over a period of approximately 16 weeks.
  
  The study will be run at hospitals and private health clinics.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  18/LO/1397

• Date of REC Opinion

  31 Oct 2018

• REC opinion

  Further Information Favourable Opinion