Trial of Linaclotide in Patients With Chronic Idiopathic Constipation
NCT ID: NCT02291679
Last Updated: 2017-06-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1223 participants
INTERVENTIONAL
2014-10-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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72 μg linaclotide
72 μg oral linaclotide, once daily for 12 weeks
Linaclotide
145 μg linaclotide
145 μg oral linaclotide, once daily for 12 weeks
Linaclotide
Placebo
matching placebo, once daily for 12 weeks
Matching Placebo
Interventions
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Linaclotide
Matching Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient has no clinically significant findings on a physical examination and clinical laboratory tests
* Patient meets protocol criteria for CIC: reports \< 3 bowel movements (BMs) per week and reports one or more of the following during ≥ 25% of BMs: straining, lumpy or hard stools, sensation of incomplete evacuation during the 3 months before the diagnosis with the onset at least 6 months before the diagnosis
* Patient is compliant with daily interactive voice response system (IVRS) calls
* Patient reports an average of \< 3 complete spontaneous BMs (CSBMs) and ≤ 6 SBMs per week by the IVRS over the 14 calendar days before the Randomization Visit and the calendar day of Randomization.
Exclusion Criteria
* 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
* Patient has Bristol Stool Form Scale score of 7 during Pretreatment period.
18 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Ironwood Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bernard J Lavins, MD
Role: STUDY_CHAIR
Ironwood Pharmaceuticals, Inc.
Locations
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Ironwood Investigational Site
Huntsville, Alabama, United States
Ironwood Investigational Site
Phoenix, Arizona, United States
Ironwood Investigational Site
Tucson, Arizona, United States
Ironwood Investigational Site
North Little Rock, Arkansas, United States
Ironwood Investigational Site
Anaheim, California, United States
Ironwood Investigational Site
Chula Vista, California, United States
Ironwood Investigational Site
Garden Grove, California, United States
Ironwood Investigational Site
La Mesa, California, United States
Ironwood Investigational Site
North Hollywood, California, United States
Ironwood Investigational Site
Orange, California, United States
Ironwood Investigational Site
San Diego, California, United States
Ironwood Investigational Site
Thousand Oaks, California, United States
Ironwood Investigational Site
Colorado Springs, Colorado, United States
Ironwood Investigational Site
Bristol, Connecticut, United States
Ironwood Investigational Site
Boynton Beach, Florida, United States
Ironwood Investigational Site
Coral Gables, Florida, United States
Ironwood Investigational Site
DeLand, Florida, United States
Ironwood Investigational Site
Hialeah, Florida, United States
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Inverness, Florida, United States
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Jupiter, Florida, United States
Ironwood Investigational Site
Kissimmee, Florida, United States
Ironwood Investigational Site
Lauderdale Lakes, Florida, United States
Ironwood Investigational Site
Miami, Florida, United States
Ironwood Investigational Site
Miami, Florida, United States
Ironwood Investigational Site
Miami, Florida, United States
Ironwood Investigational Site
Miami, Florida, United States
Ironwood Investigational Site
Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
Ironwood Investigational Site
Ormond Beach, Florida, United States
Ironwood Investigational Site
Port Orange County, Florida, United States
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South Miami, Florida, United States
Ironwood Investigational Site
Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Winter Park, Florida, United States
Ironwood Investigational Site
Atlanta, Georgia, United States
Ironwood Investigational Site
Oakwood, Georgia, United States
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Sandy Springs, Georgia, United States
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Evansville, Indiana, United States
Ironwood Investigational Site
Bastrop, Louisiana, United States
Ironwood Investigational Site
Metairie, Louisiana, United States
Ironwood Investigational Site
Shreveport, Louisiana, United States
Ironwood Investigational Site
Baltimore, Maryland, United States
Ironwood Investigational Site
Chevy Chase, Maryland, United States
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Hagerstown, Maryland, United States
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Hollywood, Maryland, United States
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Boston, Massachusetts, United States
Ironwood Investigational Site
Wellesley, Massachusetts, United States
Ironwood Investigational Site
Chesterfield, Michigan, United States
Ironwood Investigational Site
Troy, Michigan, United States
Ironwood Investigational Site
Wyoming, Michigan, United States
Ironwood Investigational Site
Jackson, Mississippi, United States
Ironwood Investigational Site
St Louis, Missouri, United States
Ironwood Investigational Site
Bozeman, Montana, United States
Ironwood Investigational Site
Las Vegas, Nevada, United States
Ironwood Investigational Site
Las Vegas, Nevada, United States
Ironwood Investigational Site
Brooklyn, New York, United States
Ironwood Investigational Site
Endwell, New York, United States
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Great Neck, New York, United States
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Charlotte, North Carolina, United States
Ironwood Investigational Site
Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
Ironwood Investigational Site
High Point, North Carolina, United States
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Lenoir, North Carolina, United States
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Raleigh, North Carolina, United States
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Wilmington, North Carolina, United States
Ironwood Investigational Site
Winston-Salem, North Carolina, United States
Ironwood Investigational Site
Fargo, North Dakota, United States
Ironwood Investigational Site
Cincinnati, Ohio, United States
Ironwood Investigational Site
Cincinnati, Ohio, United States
Ironwood Investigational Site
Columbus, Ohio, United States
Ironwood Investigational Site
Mentor, Ohio, United States
Ironwood Investigational Site
Sylvania, Ohio, United States
Ironwood Investigational Site
Oklahoma City, Oklahoma, United States
Ironwood Investigational Site
Levittown, Pennsylvania, United States
Ironwood Investigational Site
Anderson, South Carolina, United States
Ironwood Investigational Site
Greer, South Carolina, United States
Ironwood Investigational Site
Simpsonville, South Carolina, United States
Ironwood Investigational Site
Dakota Dunes, South Dakota, United States
Ironwood Investigational Site
Bristol, Tennessee, United States
Ironwood Investigational Site
Chattanooga, Tennessee, United States
Ironwood Investigational Site
Knoxville, Tennessee, United States
Ironwood Investigational Site
Beaumont, Texas, United States
Ironwood Investigational Site
Dallas, Texas, United States
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El Paso, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Longview, Texas, United States
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San Antonio, Texas, United States
Ironwood Investigational Site
San Antonio, Texas, United States
Ironwood Investigational Site
San Antonio, Texas, United States
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South Ogden, Utah, United States
Ironwood Investigational Site
Christiansburg, Virginia, United States
Ironwood Investigational Site
Lynchburg, Virginia, United States
Ironwood Investigational Site
La Crosse, Wisconsin, United States
Countries
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Other Identifiers
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MCP-103-309
Identifier Type: -
Identifier Source: org_study_id
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