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

July 16, 2008
July 17, 2011
July 2008
August 2009   (final data collection date for primary outcome measure)
Proportion of subjects achieving adequate of IBS symptoms. [ Designated as safety issue: No ]
Proportion of subjects acheiving adequate of IBS symptoms. [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00731679 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Rifaximin TID for Non-constipation Irritable Bowel Syndrome (IBS)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non-constipation Irritable Bowel Syndrome
  • Drug: Rifaximin
  • Drug: Placebo
  • Active Comparator: 1
    Intervention: Drug: Rifaximin
  • Placebo Comparator: 2
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
September 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00731679
RFIB3007
No
Audrey Shaw, Ph.D./Director, Clinical Development, Salix Pharmaceuticals, Inc.
Salix Pharmaceuticals
Not Provided
Study Director: Audrey L Shaw, Ph.D. Salix Pharmaceuticals
Salix Pharmaceuticals
July 2011

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