Trial of Linaclotide in Patients With Chronic Idiopathic Constipation



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2014
End Date:August 2015

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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide (72 ug or 145 ug) Administered Orally for 12 Weeks to Patients With Chronic Idiopathic Constipation

The objective of this trial is to determine the efficacy and safety of linaclotide
administered to patients with chronic idiopathic constipation (CIC). The primary efficacy
parameter is the percentage of patients in each dosing group that meet the protocol
definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder.


Inclusion Criteria:

- Patient has completed a colonoscopy if one is needed according to the 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 per week and
reports one or more of the following during ≥ 25% of BMs: straining, lumpy or hard
stools, sensation of incomplete evacuation

- Patient demonstrates continued chronic idiopathic constipation through Pretreatment
Period

- Patient is compliant with daily IVRS (interactive voice response system) calls

Exclusion Criteria:

- 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
We found this trial at
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Mentor, Ohio 44060
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Anaheim, California 92801
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Anderson, South Carolina 29621
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Bozeman, Montana 59718
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Bristol, Connecticut 06010
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Bristol, Tennessee 37620
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Brooklyn, New York 11206
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Chandler, Arizona 85224
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Charlotte, North Carolina 28210
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Chattanooga, Tennessee 37421
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Chesterfield, Michigan 48047
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Chevy Chase, Maryland 20815
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Chula Vista, California 91910
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Cincinnati, Ohio 45219
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Concord, North Carolina 28025
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Coral Gables, Florida 33134
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Fayetteville, North Carolina 28304
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Greensboro, North Carolina 27410
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