Status:
COMPLETED
Trial of Linaclotide in Patients With Chronic Constipation
Lead Sponsor:
Ironwood Pharmaceuticals, Inc.
Collaborating Sponsors:
Forest Laboratories
Conditions:
Chronic Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients...
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 CC: reports \< 3 bowel movements per week and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during \> 25% of BMs
- Patient demonstrates continued chronic constipation 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 Irritable Bowel Syndrome (IBS)
- 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 :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
643 Patients enrolled
Trial Details
Trial ID
NCT00730015
Start Date
August 1 2008
End Date
October 1 2009
Last Update
January 30 2013
Active Locations (105)
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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
Chandler, Arizona, United States, 85224
4
Ironwood Investigational Site
Phoenix, Arizona, United States, 85020