Rifaximin 3 Times/Day for Non-constipation IBS (TARGET 2)

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00724126
First received: July 26, 2008
Last updated: July 17, 2011
Last verified: July 2011
  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:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of subjects achieving adequate relief 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
Placebo Comparator: 1 Drug: Placebo
Experimental: 2
Rifaximin
Drug: Rifaximin

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724126

  Show 88 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 L. Shaw, Ph.D., Salix Pharmaceuticals, inc.
ClinicalTrials.gov Identifier: NCT00724126     History of Changes
Other Study ID Numbers: RFIB3008
Study First Received: July 26, 2008
Last Updated: July 17, 2011
Health Authority: United States: Food and Drug Administration

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

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 July 20, 2014