Status:
COMPLETED
Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation
Lead Sponsor:
Forest Laboratories
Collaborating Sponsors:
Ironwood Pharmaceuticals, Inc.
Conditions:
Irritable Bowel Syndrome Characterized by 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 irritable bowel syndrome with constipation (IBS-C). The primary efficacy parameter is ...
Eligibility Criteria
Inclusion
- Patient meets protocol criteria for IBS: reports abdominal discomfort or pain that has two or more of the following three features:
- Relieved with defecation
- Onset associated with a change in frequency of stool
- Onset associated with a change in form (appearance) of stool
- Patient reports \< 3 bowel movements (BMs) per week (in the absence of any laxative, suppository, or enema use during the preceding 24 hours) and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during \> 25% of BMs
- Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests (some patients may require a colonoscopy per American Gastroenterological Association (AGA) guidelines)
- Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting of BM habits and IBS symptoms
Exclusion
- Patient has history of loose or watery stools for \>25% of BMs
- Patient has a structural abnormality of the gastrointestinal (GI) tract or a history of a disease or condition that can affect GI motility
- Patient has any protocol-excluded or clinically significant medical or surgical history or concomitant medication use that could confound the study assessments
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
803 Patients enrolled
Trial Details
Trial ID
NCT00948818
Start Date
July 1 2009
End Date
August 1 2010
Last Update
January 30 2013
Active Locations (118)
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1
Forest Investigative Site 037
Birmingham, Alabama, United States, 35209
2
Forest Investigative Site 036
Birmingham, Alabama, United States, 35215
3
Forest Investigative Site 135
Hueytown, Alabama, United States, 35023
4
Forest Investigative Site 014
Huntsville, Alabama, United States, 35801