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Tracking Information | |
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First Received Date † | December 22, 2005 |
Last Updated Date | December 6, 2007 |
Start Date † | December 2005 |
Current Primary Outcome Measures † |
The primary objective of this trial is to evaluate the efficacy of a 14-day course of oral rifaximin at 550 mg BID versus placebo in providing adequate relief from Diarrhea-associated IBS (DIBS) symptoms. |
Original Primary Outcome Measures † | Same as current |
Change History | Complete list of historical versions of study NCT00269412 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |
Brief Title † | Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome |
Official Title † | Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess The Efficacy and Safety of Three Different Doses (275, 550 AND 1100 MG) of Rifaximin Administered BID For Either Two or Four Weeks in The Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome |
Brief Summary | This is placebo-controlled study of three rifaximin doses in patients with DIBS. Subjects will be randomized to receive daily doses of placebo BID, rifaximin 275 mg BID, rifaximin 550 mg BID, or 1100 mg BID for 14 days. These four groups will subsequently receive an additional two weeks of placebo for a total of 4 weeks of treatment. A fifth group of subjects will receive rifaximin 550 mg BID for a period of 28 days. Subjects who successfully respond to treatment at the end of the 28-day Treatment Phase will be followed in a Post-treatment Phase that includes study visits during Weeks 6, 8, 12 and 16. Subjects who relapse during the Post-treatment Phase will be discontinued from the study. |
Detailed Description | While IBS is one of the most common chronic medical conditions the etiology of IBS is unknown. Although not a life-threatening illness, IBS is considered to be a serious condition that has a substantial impact on a subject's day-to-day function. IBS is characterized by abdominal pain and altered bowel habits, including diarrhea, constipation, or alternating diarrhea and constipation. Symptoms are typically intermittent but may be continuous. |
Study Phase | Phase II |
Study Type † | Interventional |
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Condition † | Irritable Bowel Syndrome |
Intervention † | Drug: Rifaximin |
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Completed |
Enrollment † | 525 |
Completion Date | |
Primary Completion Date | |
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00269412 |
Responsible Party | |
Secondary IDs †† | |
Study Sponsor † | Salix Pharmaceuticals |
Collaborators †† | |
Investigators † | |
Information Provided By | Salix Pharmaceuticals |
Verification Date | December 2007 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |