Status:
COMPLETED
Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation
Lead Sponsor:
Sucampo Pharma Americas, LLC
Collaborating Sponsors:
Takeda
Conditions:
Irritable Bowel Syndrome With Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
590 Patients enrolled
Trial Details
Trial ID
NCT00380250
Start Date
May 1 2005
End Date
July 1 2006
Last Update
November 15 2019
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