Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)



Status:Recruiting
Conditions:Constipation, Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2015

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A Phase 2b, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Dose-range-finding Study of Two Delayed Release Formulations of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation

The objectives of this study are to evaluate the safety, efficacy, and dose response of two
delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2
is DR2) administered orally to patients with irritable bowel syndrome with constipation
(IBS-C). Additional objectives include understanding how the two DR formulations compare
with each other and with the FDA-approved 290 μg LINZESS® (the immediate release [IR]
formulation of linaclotide).


Inclusion Criteria:

- Patient has completed a colonoscopy 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 diagnosis of IBS-C

- Patient demonstrates continued IBS-C through Pretreatment Period

- Patient maintains a minimum level of compliance with daily diary

Exclusion Criteria:

- Patient has history of loose or watery stools

- Patient has symptoms of or been diagnosed with a medical condition that may
contribute to abdominal pain

- 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
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Las Vegas, Nevada 89119
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Anaheim, California 92801
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Bastrop, Louisiana 71220
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Boston, Massachusetts 02131
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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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Charlotte, North Carolina 28210
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Chesterfield, Michigan 48047
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Chevy Chase, Maryland 20815
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