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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00724126
Other study ID # RFIB3008
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 2008
Est. completion date September 2009

Study information

Verified date November 2019
Source Bausch Health Americas, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 637
Est. completion date September 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Confirmed IBS diagnosis per Rome II criteria 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rifaximin

Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pimentel M, Lembo A, Chey WD, Zakko S, Ringel Y, Yu J, Mareya SM, Shaw AL, Bortey E, Forbes WP; TARGET Study Group. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011 Jan 6;364(1):22-32. doi: 10.1056/NEJM — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 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]"
4 weeks
Secondary 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) 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]."
4 weeks
See also
  Status Clinical Trial Phase
Completed NCT00731679 - Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS) Phase 3
Completed NCT02079675 - Study to Assess the Efficacy and Safety of SKI3246 in Subjects With Non-Constipation Irritable Bowel Syndrome Phase 2