Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation

Phase 3, 12-Week, Multicenter, Double-Blind, Randomized, Efficacy and Safety Study of Lubiprostone for the Treatment of Irritable Bowel Syndrome With Constipation

The primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation.

Inclusion Criteria:

• 18 years of age and older
• Stable fiber therapy
• Normal colonoscopy/sigmoidoscopy
• Able to refrain from use of medications known to treat or associated with constipation symptoms
• Experiences abdominal discomfort/pain associated with bowel movements
• Reports decreased bowel movement frequency and/or other symptoms associated with constipation

Exclusion Criteria:

• Diarrhea-predominant or alternating (diarrhea and constipation cycling) irritable bowel syndrome (IBS), or constipation other than that associated with IBS
• Open gastrointestinal or abdominal surgery prior to IBS onset
• Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained weight loss or rectal bleeding
• Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests per investigator discretion
• If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study