Trial Information

Summary: Irritable Bowel Syndrome w/ Diarrhea and alternating constipation

This is a Phase 2B, randomized, double-blind placebo controlled study for the safety and efficacy of a study in 100, 200 and 300 mg BID compared to placebo in female patients with diarrhea predominant or mixed IBS. This is a 19 week study consisting of 6 office visits. You will be compensated for your time and travel upon completion of study. A colonoscopy will also be performed

Patient Inclusion Criteria:

• Female 18 to 65
• Must be using acceptable form of birth control

Patient Exclusion Criteria:

• Allergy of benzodiazepine
• Insulin dependent diabetics
• BMI greater than 40
• Anemia,gastrointestinal bleeding, gallbladder disease,diverticulitis within 12 months
• Hep A(within 2 years)B,C or HIV
• History of Cancer with in 5 years (except BBC or SCC)
• History of seizure disorder
• Alcohol or substance abuse within 6 months

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Trial listings updated: June 1, 2008 at 6:46:01 AM