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

Irritable Bowel Syndrome With Diarrhea Clinical Trial

— TARGET3  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543178
• Other study ID #: RFIB3053
• Status: Completed
• Phase: Phase 3
• First received: February 27, 2012
• Last updated: December 8, 2017
• Start date: February 2012
• Est. completion date: June 2014

Study information

• Verified date: December 2017
• Source: Valeant Pharmaceuticals International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 single-blind placebo 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. Nonresponders 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 at the end of the Treatment 3 Phase (at Week 6 of the double-blind period).

Maintenance Phase 2. All subjects continued into an additional treatment-free follow-up period of up to 6 weeks (Maintenance Phase 2).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2583
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 previous 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.

• Unstable cardiovascular or pulmonary disease, with change in treatment in last 30 days due to worsening disease condition.

• History of GI surgery.

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Diarrhea
• Syndrome

Intervention

Drug:
• open-label rifaximin
550 mg three times a day (open-label)
• double-blind placebo
3 times a day (double-blind)
• double-blind rifaximin
550 mg three times a day (double-blind)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Valeant Pharmaceuticals International, Inc.

Countries where clinical trial is conducted

United States,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repeat Treatment Responders	Subjects who respond to repeat treatment in both IBS-related abdominal pain and stool consistency. The proportion of patients who responded to repeat treatment during the first double-blind repeat treatment phase is presented. Response is defined as improvement from baseline in abdominal pain AND reduction from baseline in diarrhea.	4-week treatment-free follow-up in double-blind repeat treatment phase.