IBS-D Rifaximin Re-Treatment Study (TARGET 3)
Research type
Research Study
Full title
A Study to Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 mg TID in Subjects with Irritable Bowel Syndrome with Diarrhoea (IBS-D)
IRAS ID
137025
Contact name
Peter Whorwell
Contact email
Sponsor organisation
Salix Pharmaceuticals, Inc.
Eudract number
2013-002394-22
Clinicaltrials.gov Identifier
Research summary
Salix Pharmaceuticals Inc is developing rifaximin for Irritable Bowel Syndrome with Diarrhoea (IBS-D). It is important in chronic conditions to have information about how a product that is intended for short course administration, in order to confer prolonged benefit, should be administered beyond the first cycle of use once symptoms re-appear. This Phase 3 study will evaluate the efficacy and safety of repeat treatment with rifaximin 550mg three times daily (TID) for 14 days in subjects with IBS-D who respond to an initial treatment course with rifaximin for 14 days. The study consists of several treatment and follow-up/maintenance treatment-free phases and participants are asked to answer daily IBS symptom-related questions. During each phase non-responders will be withdrawn. All eligible subjects will receive open-label rifaximin 550mg TID for 2 weeks with a 4-week treatment-free follow-up. Responders will continue into a maintenance phase, a treatment-free follow-up period for up to 18 weeks until either: 1) they experience recurrence or 2) enrollment is met in the Double Blind Randomised (DBR) Phase. Subjects who meet criteria for recurrence will be randomized 1:1 to receive either rifaximin 550 mg TID or placebo (inactive dummy drug) TID for 2 weeks with a 4-week treatment-free follow-up. A primary analysis of data will then be performed after 6 weeks (end of the DBR Phase). All participants will be eligible for maintenance phase 2 and will continue an additional treatment-free follow-up period of up to 6 weeks. Particiants will then receive the same double-blind treatment as previously assigned in the DBR Phase for 2 weeks. This will be followed by an 8-week follow-up period until the end of study visit. The primary analysis will look at the proportion of responders to repeat treatment for both abdominal pain and stool consistency during the DBR phase.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
13/NW/0586
Date of REC Opinion
26 Sep 2013
REC opinion
Further Information Favourable Opinion