3002: 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
108960
Contact name
Adam Farmer
Sponsor organisation
Furiex Pharmaceuticals
Eudract number
2012-001601-24
Clinicaltrials.gov Identifier
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 34 weeks or 8 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) and a 30-week treatment phase. After randomisation participants will return to the clinic at Weeks 2, 4, 8, 12, 18, and 26. An end of treatment visit will be performed at week 30. 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) (Every participant at some point in the study will receive placebo medication, even if assigned to the 75 mg twice daily group or 100 mg twice daily study group. Participants will not know at which time point the placebo is administered). This study involves procedures including:- Physical examination, vital signs, ECGs, blood tests, urine tests, health questionnaires and completion of an electronic diary
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
12/WM/0194
Date of REC Opinion
13 Aug 2012
REC opinion
Further Information Favourable Opinion