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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North Little Rock, Arkansas 72117
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Anaheim, California 92801
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Anderson, South Carolina 29621
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Asheville, North Carolina 28801
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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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Boynton Beach, Florida 33426
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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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Christiansburg, Virginia 24073
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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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Columbus, Ohio 43215
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Concord, North Carolina 28025
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Coral Gables, Florida 33134
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Dakota Dunes, South Dakota 57049
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Dallas, Texas 75230
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Davidson, North Carolina 28036
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DeLand, Florida 32720
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El Paso, Texas 79905
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Endwell, New York 13760
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Evansville, Indiana 47714
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Fargo, North Dakota 58103
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Fayetteville, North Carolina 28304
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Florissant, Missouri 63033
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Garden Grove, California 92843
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Great Neck, New York 11023
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Greensboro, North Carolina 27410
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Greer, South Carolina 29651
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Hagerstown, Maryland 21742
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Hialeah, Florida 33016
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High Point, North Carolina 27262
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Inverness, Florida 34452
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Jackson, Mississippi 39202
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Jupiter, Florida 33458
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Kissimmee, Florida 34741
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La Crosse, Wisconsin 54601
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La Mesa, California 91942
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Las Vegas, Nevada 89119
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Lauderdale Lakes, Florida 33319
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Nashville, Tennessee 37212
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Newport Beach, California 92660
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North Hollywood, California 91606
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Oakwood, Georgia 30566
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Orange, California 92868
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Plymouth, Minnesota 55446
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Raleigh, North Carolina 27612
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Saint Louis, Missouri 63128
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San Antonio, Texas 78209
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