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Rifaximin TID for Non-constipation Irritable Bowel Syndrome (IBS) (TARGET 1)

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00731679
First received: July 16, 2008
Last updated: July 17, 2011
Last verified: July 2011
History of Changes
  Purpose

To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of IBS symptoms.


Condition Intervention Phase
Non-constipation Irritable Bowel Syndrome
 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, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin 550 mg TID in the Treatment of Subjects With Non-constipation Irritable Bowel Syndrome

Resource links provided by NLM:

Drug Information available for: Rifaximin
U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of subjects achieving adequate of IBS symptoms. [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: July 2008
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Rifaximin
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed IBS diagnosis per Rome II
  • Colonoscopy within 2 years as part of IBS diagnostic evaluation
  • Meets average daily scores for abdominal pain/discomfort, bloating and stool consistency

Exclusion Criteria:

  • Symptoms of constipation
  • History of other GI diseases
  • Type 1 or 2 diabetes
  • Lactose intolerance not controlled by lactose-free diet
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731679

  Show 96 Study Locations
Sponsors and Collaborators
Salix Pharmaceuticals
Investigators
Study Director: Audrey L Shaw, Ph.D. Salix Pharmaceuticals
  More Information

No publications provided by Salix Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Audrey Shaw, Ph.D./Director, Clinical Development, Salix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00731679     History of Changes
Other Study ID Numbers: RFIB3007
Study First Received: July 16, 2008
Last Updated: July 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
IBS
Abdominal pain
Bloating
Diarrhea
Rifaximin

Additional relevant MeSH terms:
Irritable Bowel Syndrome
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 May 16, 2013