Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study (TARGET3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01543178
First received: February 27, 2012
Last updated: August 15, 2014
Last verified: December 2013

February 27, 2012
August 15, 2014
February 2012
Not Provided
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.
Same as current
Complete list of historical versions of study NCT01543178 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Irritable Bowel Syndrome With Diarrhea
  • Drug: rifaximin
    550 mg three times a day
    Other Name: rifaximin
  • Drug: placebo
    3 times a day
    Other Name: Placebo
  • Placebo Comparator: placebo
    Placebo
    Intervention: Drug: placebo
  • Experimental: rifaximin
    rifaximin 550 mg
    Intervention: Drug: rifaximin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
Not Provided
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Inclusion Criteria:

  1. IBS confirmed by Rome III diagnostic criteria
  2. At least 18 years of age
  3. 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.
  4. Willing to maintain a stable diet. including vitamins, supplements and nutraceuticals.

Exclusion Criteria:

  1. Diabetes (Type 1 or 2)
  2. Lactose intolerance and not controlled by a lactose-free diet
  3. Pregnant or planning to become pregnant or is lactating
  4. History of HIV or hepatitis B or C
  5. Participation in investigational study within past 30 days
  6. Taking rifaximin or any other antibiotic within past 60 days
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom,   Germany
 
NCT01543178
RFIB3053
No
Salix Pharmaceuticals
Salix Pharmaceuticals
Not Provided
Study Director: Enoch Bortey, PhD Salix Pharmaceuticals
Salix Pharmaceuticals
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP