Trial Information

Summary: A Phase 2, 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

The purpose of this study is to demonstrate the efficacy of a 14-day course of oral rifaximin versus placebo in providing adequate relief from Diarrhea-associated IBS (DIBS) symptoms.

Inclusion Criteria: Men and women 18 years and older suffering from irritable bowel syndrome.

Exclusion Criteria: Patient has exclusively constipation-predominant IBS (CIBS) that is characterized by 3 bowel movements/week or hard and lumpy stools. Current evidence of duodenal ulcer, gastric ulcer, or gastroesophageal reflux disease (GERD), uncontrolled by medication; diverticulitis, gastroparesis, history of inflammatory bowel disease (Crohn’s disease or ulcerative colitis), history of celiac disease, gastrointestinal cancer, gastrointestinal obstruction, carcinoid syndrome, pancreatitis, cholelithiasis, amyloidosis, or ileus. Patients with protocol deviations deemed to have a significant impact on efficacy variables will be excluded.

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Trial listings updated: June 1, 2008 at 5:46:16 AM