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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Xenia, Ohio 45385
Phone: 937-912-4444
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Anaheim, California 92801
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Arlington, Texas 76012
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Atlanta, Georgia 30328
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Baltimore, Maryland 21215
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Bastrop, Louisiana 71220
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Beaumont, Texas 77701
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Boston, Massachusetts 02131
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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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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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Cincinnati, Ohio 45219
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Colorado Springs, Colorado 80904
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Concord, North Carolina 28025
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Dakota Dunes, South Dakota 57049
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Davidson, North Carolina 28036
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El Paso, Texas 79905
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Evansville, Indiana 47714
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Fayetteville, North Carolina 28304
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Houston, Texas 77015
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Mentor, Ohio 44060
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Metairie, Louisiana 70006
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Miami, Florida 33122
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Newport Beach, California 92660
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North Little Rock, Arkansas 72117
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Oakwood, Georgia 30566
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Ogden, Utah 84405
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San Diego, California 92108
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Shreveport, Louisiana 71105
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Waterbury, Connecticut 06708
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Watertown, Massachusetts 02472
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West Palm Beach, Florida 33409
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