Status:
COMPLETED
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Lead Sponsor:
Ironwood Pharmaceuticals, Inc.
Collaborating Sponsors:
Forest Laboratories
Conditions:
Irritable Bowel Syndrome With Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).
Eligibility Criteria
Inclusion
- Patient has completed a colonoscopy according to the AGA criteria, with no clinically significant findings
- Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests
- Patient meets protocol criteria for diagnosis of IBS-C
- Patient demonstrates continued IBS-C through Pretreatment Period
- Patient is compliant with IVRS
Exclusion
- Patient has history of loose or watery stools
- Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
- Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
- Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
805 Patients enrolled
Trial Details
Trial ID
NCT00938717
Start Date
July 1 2009
End Date
September 1 2010
Last Update
November 5 2013
Active Locations (107)
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1
Ironwood Investigational Site
Birmingham, Alabama, United States, 35209
2
Ironwood Investigational Site
Huntsville, Alabama, United States, 35801
3
Ironwood Investigational Site
Phoenix, Arizona, United States, 85014
4
Ironwood Investigational Site
Tempe, Arizona, United States, 85282