Status:
COMPLETED
Trial of Linaclotide in Patients With Chronic Idiopathic Constipation
Lead Sponsor:
Ironwood Pharmaceuticals, Inc.
Collaborating Sponsors:
Forest Laboratories
Conditions:
Chronic Idiopathic Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter...
Detailed Description
The trial also included a 145 ug linaclotide treatment arm (an FDA-approved dose for CIC) as an established positive control to validate the study design.
Eligibility Criteria
Inclusion
- Patient has completed a colonoscopy if one is needed according to the American Gastroenterological Association (AGA) criteria, with no clinically significant findings
- Patient has no clinically significant findings on a physical examination and clinical laboratory tests
- Patient meets protocol criteria for CIC: reports \< 3 bowel movements (BMs) per week and reports one or more of the following during ≥ 25% of BMs: straining, lumpy or hard stools, sensation of incomplete evacuation during the 3 months before the diagnosis with the onset at least 6 months before the diagnosis
- Patient is compliant with daily interactive voice response system (IVRS) calls
- Patient reports an average of \< 3 complete spontaneous BMs (CSBMs) and ≤ 6 SBMs per week by the IVRS over the 14 calendar days before the Randomization Visit and the calendar day of Randomization.
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
- Patient has Bristol Stool Form Scale score of 7 during Pretreatment period.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
1223 Patients enrolled
Trial Details
Trial ID
NCT02291679
Start Date
October 1 2014
End Date
August 1 2015
Last Update
June 15 2017
Active Locations (95)
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1
Ironwood Investigational Site
Huntsville, Alabama, United States, 35801
2
Ironwood Investigational Site
Phoenix, Arizona, United States, 85018
3
Ironwood Investigational Site
Tucson, Arizona, United States, 85712
4
Ironwood Investigational Site
North Little Rock, Arkansas, United States, 72117