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Sponsored by: |
Salix Pharmaceuticals |
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Information provided by: | Salix Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00269412 |
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.
Condition | Intervention | Phase |
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Irritable Bowel Syndrome |
Drug: Rifaximin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 525 |
Study Start Date: | December 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | RFIB2001 |
Study First Received: | December 22, 2005 |
Last Updated: | December 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00269412 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Irritable bowel syndrome |
Anti-Infective Agents Digestive System Diseases Diarrhea Gastrointestinal Diseases Colonic Diseases |
Irritable Bowel Syndrome Rifaximin Intestinal Diseases Colonic Diseases, Functional |
Anti-Infective Agents Disease Gastrointestinal Diseases Colonic Diseases Gastrointestinal Agents Intestinal Diseases Pharmacologic Actions |
Digestive System Diseases Pathologic Processes Syndrome Therapeutic Uses Irritable Bowel Syndrome Rifaximin Colonic Diseases, Functional |