Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study (TARGET3)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Irritable Bowel Syndrome With Diarrhea |
Drug: rifaximin Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 800 |
| Study Start Date: | February 2012 |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: placebo
Placebo
|
Drug: placebo
3 times a day
Other Name: Placebo
|
|
Experimental: rifaximin
rifaximin 550 mg
|
Drug: rifaximin
550 mg three times a day
Other Name: rifaximin
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- IBS confirmed by Rome III diagnostic criteria
- At least 18 years of age
- Colonoscopy within the past 10 years to rule out inflammatory bowel disease or flexible sigmoidoscopy if < 50 years of age or colonoscopy > 10 years prior.
- Willing to maintain a stable diet. including vitamins, supplements and nutraceuticals.
Exclusion Criteria:
- Diabetes (Type 1 or 2)
- Lactose intolerance and not controlled by a lactose-free diet
- Pregnant or planning to become pregnant or is lactating
- History of HIV or hepatitis B or C
- Participation in investigational study within past 30 days
- Taking rifaximin or any other antibiotic within past 60 days
Contacts and Locations| Contact: Rachel Ballard | rachel.ballard@salix.com | |
| Contact: Alyson Lineberry | alyson.lineberry@salix.com |
Show 300 Study Locations| Study Director: | Enoch Bortey, PhD | Salix Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Salix Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01543178 History of Changes |
| Other Study ID Numbers: | RFIB3053 |
| Study First Received: | February 27, 2012 |
| Last Updated: | May 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Salix Pharmaceuticals:
|
IBS IBS-D IBS with diarrhea Diarrhea Irritable bowel syndrome with diarrhea |
Additional relevant MeSH terms:
|
Diarrhea Irritable Bowel Syndrome Signs and Symptoms, Digestive Signs and Symptoms Colonic Diseases, Functional Colonic Diseases Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Rifaximin Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 17, 2013