3001: Phase 3 Study of JNJ-27018966 in Patients with IBS-d

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome

• IRAS ID

  106420

• Contact name

  Adam Farmer

• Sponsor organisation

  Furiex Pharmaceuticals

• Eudract number

  2012-001600-38

• Clinicaltrials.gov Identifier

  NCT01553591

• Research summary

  This is a phase III randomised, double-blind, placebo-controlled efficacy and safety study funded by Furiex Pharmaceuticals. The purpose of this study is to find out if a new investigational drug called JNJ-27018966 is safe and effective as a treatment for diarrhea-predominant Irritable Bowel Syndrome (IBS-d). It is expected that approximately 1125 subjects will be included in this study in the US, Canada and the UK. It is expected that approximately 50 participants will be recruited in the UK. The duration of participation is expected to be about 58 weeks or 13.5 months. The study will consist of a pre-treatment phase (consisting of an up to 1-week pre-screening period and an up to 3-week screening period), a 52-week double-blind treatment phase and a 2-week post-treatment follow-up period. After randomisation, participants will return for clinic visits at weeks 2, 4, 8, 12, 18, 26, 36, 44 and 52. A post-treatment follow-up visit will occur at Week 54 for patients who complete the study. Participants will be randomised (1:1:1) to one of 3 treatment groups: ?½ Group 1: JNJ-27018966, 75 mg twice daily (150 mg total daily dose) ?½ Group 2: JNJ-27018966, 100 mg twice daily (200 mg total daily dose) ?½ Group 3: placebo twice daily (placebo is a pill that looks like JNJ-27018966 but has no active ingredient) This study involves procedures including:- Physical examination, vital signs, ECGs, blood tests, urine tests, health questionnaires, completion of electronic diary

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  12/WM/0193

• Date of REC Opinion

  13 Aug 2012

• REC opinion

  Further Information Favourable Opinion