Motilin Agonist in Diabetic Gastroparesis

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase II Study to Evaluate the Safety and Efficacy and Dose Response of 28 Days of Once-Daily Dosing of the Oral Motilin Receptor Agonist GSK962040, in Type I and II Diabetic Male and Female Subjects with Gastroparesis

• IRAS ID

  68375

• Contact name

  Odile E Dewit

• Eudract number

  2010 - 023186 - 21

• ISRCTN Number

  not issued

• Research summary

  This clinical trial is in 18 to 80 years old men and women who have Type 1 or Type 2 diabetes and gastroparesis, a condition with slow emptying of food from the stomach and with gastrointestinal (GI) symptoms such as chronic post-prandial fullness, early satiety and post-prandial nausea for example. The trial drug, named GSK962040, which stimulates the motilin receptors, accelerated the emptying of food and fluid from the stomach, and was well tolerated in clinical trials of doses up to 125 mg/day for 14 days in healthy volunteers. The patients may gain benefit from taking part in this trial if they respond to GSK962040 with an accelerated emptying of the stomach and with an improvement of their GI symptoms. The criteria to screen patients for eligibility for the trial include 1) the speed of the stomach-emptying of a test-meal, measured by collecting breath samples and via a wireless motility capsule (to be swallowed, then moves through the gullet, stomach and bowels and is passed harmlessly in the stools), and 2) a 3-month pre-screening and a 7-day pre-dose history of relevant symptoms of gastroparesis. The eligible patients will be allocated randomly to receive a dummy pill or 10, 50 or 125 mg of GSK962040 daily for their 28-day treatment. The patients and the study team will not know which treatment was allocated until the end of the trial. For each patient, there are approximately 9 visits to the research center over approximately 10 weeks. A formal analysis during the trial (called interim analysis) will review the trial design to adapt it if required for optimal scientific value. The trial, funded by GlaxoSmithKline (GSK), is multi-national (North America and Europe). In the UK, approximately 24 patients will be recruited via NHS consultants and non-NHS research centers, including via advertisements.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/H0707/8

• Date of REC Opinion

  14 Mar 2011

• REC opinion

  Further Information Favourable Opinion