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

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3

Details

• Lead Sponsor: Sucampo Pharma Americas, LLC; Sucampo Pharmaceuticals, Inc.
• Collaborators: Sucampo Pharmaceuticals, Inc.; Takeda
• Treatments: Lubiprostone

Criteria

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 & constipation cycling) 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