Status:
COMPLETED
A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Ironwood Pharmaceuticals, Inc.
Conditions:
Irritable Bowel Syndrome With Constipation (IBS-C)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This clinical trial is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo. Approximately 800 patients with a...
Eligibility Criteria
Inclusion
- Patient has signed an Informed Consent Form(ICF).
- Patient Must not be pregnant or breastfeeding and agree to use birth control
- Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines and no clinically-significant laboratory or physical examination findings;
- Patient meets protocol-defined criteria for Irritable Bowel Syndrome with Constipation(IBS-C), including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria
- Patient meets protocol-defined eDiary completion Compliance and agrees to refrain from making any new, major life-style changes that may affect IBS-C symptoms
Exclusion
- Recent history of mushy or watery stools
- Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study
- Patient currently has both unexplained and clinically significant alarm symptoms or systemic signs of infection or colitis.
- Surgery to the gastrointestinal tract
- Usage of prohibited medications
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
1722 Patients enrolled
Trial Details
Trial ID
NCT01880424
Start Date
July 1 2013
End Date
May 1 2015
Last Update
September 27 2016
Active Locations (82)
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1
Research Site
Huntsville, Alabama, United States
2
Research Site
North Little Rock, Arkansas, United States
3
Research Site
Phoenix, Arkansas, United States
4
Research Site
Artesia, California, United States