A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation



Status:Active, not recruiting
Conditions:Constipation, Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:1/16/2019
Start Date:June 20, 2018
End Date:June 2019

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A Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide 290 μg Administered Orally for 12 Weeks Followed by a 4-week Randomized Withdrawal Period in Patients With Irritable Bowel Syndrome With Constipation

To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and
abdominal pain) and safety of linaclotide 290 μg administered orally to patients with
irritable bowel syndrome with constipation (IBS-C).

12 week treatment period followed by 4-week Randomized Withdrawal (RW) Period.

Inclusion Criteria:

- Patient has no clinically significant findings on a physical examination and clinical
laboratory tests

- Female patients of childbearing potential must agree to use one of the following
methods of birth control:

1. Hormonal contraception

2. Double-barrier birth control

3. Maintenance of a monogamous relationship with a male partner who has been
surgically sterilized by vasectomy

- Patient meets protocol criteria for diagnosis of IBS-C

- Patient demonstrates continued IBS-C symptoms 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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Sunrise, Florida 33351
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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4410 Medical Drive
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500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
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1897 Palm Beach Lakes Boulevard
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Baltimore, Maryland 21215
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Boston, Massachusetts 02135
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Bozeman, Montana 59718
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39 Brewster Road
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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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2711 North Orange Blossom Trail
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
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1907 Tradd Ct
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1901 S Hawthorne Rd #306
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