Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study (TARGET3)
This study will evaluate the effectiveness and safety of repeat treatment with rifaximin 550 mg three times a day in patients with IBS with diarrhea who respond to initial treatment of rifaximin 550 mg three times a day.
Irritable Bowel Syndrome With Diarrhea
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Study to Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 mg TID in Subjects With Irritable Bowel Syndrome With Diarrhea (IBS-D)|
- Repeat Treatment Responders [ Time Frame: 4-week treatment-free follow-up in double-blind repeat treatment phase. ] [ Designated as safety issue: No ]Subjects who respond to repeat treatment in both IBS-related abdominal pain and stool consistency.
|Study Start Date:||February 2012|
Placebo Comparator: placebo
3 times a day
Other Name: Placebo
rifaximin 550 mg
550 mg three times a day
Other Name: rifaximin
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 reappear. This Phase 3 study will evaluate the efficacy and safety of repeat treatment with rifaximin 550 mg three times daily (TID) for 14 days in subjects with IBS-D who respond to an initial treatment course with rifaximin 550 mg TID for 14 days.
This study consists of several treatment phases outlined below:
Screening/Treatment 1 Phase. Subjects will receive study drug TID for 7-13 days and answer daily IBS symptom-related questions.
Treatment 2 Phase. Eligible subjects will receive open-label rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up. Responders will continue into Maintenance Phase 1. Non-responders will withdraw from the study.
Maintenance Phase 1. Subjects will continue the treatment-free follow-up period for up to 18 weeks until either: 1) they experience recurrence or 2) enrollment is met in the Treatment 3 Phase (Double Blind Repeat Treatment Phase). Subjects who do not meet recurrence criteria by the end of the Maintenance Phase 1 will withdraw from the study.
Treatment 3 Phase/ Double Blind Repeat Treatment Phase. Subjects who meet criteria for recurrence will be randomized 1:1 to receive either rifaximin 550 mg TID or placebo TID for 2 weeks with a 4-week treatment-free follow-up.
Primary efficacy analysis will be performed after 6 weeks (end of the Treatment 3 Phase).
Maintenance Phase 2. All subjects will be eligible for Maintenance Phase 2 and will continue with an additional treatment-free follow-up period of up to 6 weeks.
Treatment 4 Phase/Second Repeat Treatment Phase. Subjects will receive the same double-blind treatment as previously assigned in the Treatment 3 Phase for 2 weeks with a 4-week treatment-free follow-up.
A lactulose breath test sub-study will be conducted at select sites.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543178
Show 297 Study Locations
|Study Director:||Enoch Bortey, PhD||Salix Pharmaceuticals|