Phase 3 N=2,583 Randomized Double-blind Treatment

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

Irritable Bowel Syndrome With Diarrhea

Bottom Line

View on ClinicalTrials.gov: NCT01543178 ↗

Enrolled (actual)

2,583

Serious AEs

1.1%

Results posted

Jul 2015

Primary outcome: Primary: Repeat Treatment Responders — 32.6; 25.0 percentage of patients — p=0.0232

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: open-label rifaximin (Drug); double-blind placebo (Drug); double-blind rifaximin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bausch Health Americas, Inc.
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Repeat Treatment Responders	32.6; 25.0	0.0232 sig

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.

Eligibility Criteria

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01543178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.