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 |
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).
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
We found this trial at
78
sites
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860 Peachwood Drive
DeLand, Florida 32720
DeLand, Florida 32720
(386) 740-0770
Phone: 386-785-0074
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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77 West Granada Boulevard
Ormond Beach, Florida 32174
Ormond Beach, Florida 32174
Phone: 386-677-0453
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500 Chase Parkway
Waterbury, Connecticut 06708
Waterbury, Connecticut 06708
203-419-4420
Phone: 203-721-6040
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1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
West Palm Beach, Florida 33409
561-689-0606
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39 Brewster Road
Bristol, Connecticut 06010
Bristol, Connecticut 06010
Phone: 860-585-3838
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801 Monterey Street
Coral Gables, Florida 33134
Coral Gables, Florida 33134
Phone: 305-445-5637
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2711 North Orange Blossom Trail
Kissimmee, Florida 34744
Kissimmee, Florida 34744
Phone: 321-337-0700
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
Raleigh, North Carolina 27612
(919) 781-2514
Phone: 919-781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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1907 Tradd Ct
Wilmington, North Carolina 28401
Wilmington, North Carolina 28401
(910) 799-5500
Phone: 910-815-6108
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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Winston-Salem, North Carolina 27103
Phone: 336-768-3456
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
(336) 768-8062
Phone: 336-768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
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