Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS) (TARGET 1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00731679
First received: July 16, 2008
Last updated: June 30, 2014
Last verified: June 2014

July 16, 2008
June 30, 2014
July 2008
August 2009   (final data collection date for primary outcome measure)
Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of global IBS symptoms was defined as a response of "yes" to the following question, which was asked weekly (every 7 days): "In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/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
Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The secondary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of bloating was defined as a response of "yes" to the following question, which was asked weekly (every 7 days): "In regard to your symptom of bloating, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? [Yes/No]."
Not Provided
Not Provided
Not Provided
 
Rifaximin 3 Times/Day (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
  • Placebo Comparator: Placebo
    Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
    Intervention: Drug: Placebo
  • Experimental: Rifaximin
    Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
    Intervention: Drug: Rifaximin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
623
September 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed IBS diagnosis per Rome II for diagnosis of IBS.
  • Colonoscopy within 2 years as part of IBS diagnostic evaluation.
  • Has active symptoms of non-constipation IBS at baseline as measured by average daily scores for abdominal pain/discomfort, bloating, and stool consistency.

Exclusion Criteria:

  • Symptoms of constipation.
  • History of other gastrointestinal 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
Salix Pharmaceuticals
Salix Pharmaceuticals
Not Provided
Study Director: Enoch Bortey Salix Pharmaceuticals
Salix Pharmaceuticals
June 2014

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