Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study (TARGET3)
|First Received Date ICMJE||February 27, 2012|
|Last Updated Date||December 9, 2013|
|Start Date ICMJE||February 2012|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01543178 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study|
|Official Title ICMJE||A Study to Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 mg TID in Subjects With Irritable Bowel Syndrome With Diarrhea (IBS-D)|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Condition ICMJE||Irritable Bowel Syndrome With Diarrhea|
|Study Arm (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||800|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States, Germany, United Kingdom|
|NCT Number ICMJE||NCT01543178|
|Other Study ID Numbers ICMJE||RFIB3053|
|Has Data Monitoring Committee||No|
|Responsible Party||Salix Pharmaceuticals|
|Study Sponsor ICMJE||Salix Pharmaceuticals|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Salix Pharmaceuticals|
|Verification Date||December 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP