Overview

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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sucampo Pharma Americas, LLC
Sucampo Pharmaceuticals, Inc.
Collaborator:
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 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