Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT ID: NCT00460811
Last Updated: 2013-02-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
420 participants
INTERVENTIONAL
2007-04-30
2008-04-30
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 ug linaclotide acetate
Linaclotide Acetate
Oral, once daily
145 ug linaclotide acetate
Linaclotide Acetate
Oral, once daily
290 ug linaclotide acetate
Linaclotide Acetate
Oral, once daily
579 ug linaclotide acetate
Linaclotide Acetate
Oral, once daily
Matching Placebo
Matching placebo
Oral, once daily
Interventions
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Linaclotide Acetate
Oral, once daily
Matching placebo
Oral, once daily
Eligibility Criteria
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Inclusion Criteria
* Completion of a negative colonoscopy as per American Gastroenterology Association (AGA) criteria and no clinically-significant laboratory or physical examination findings;
* Meets protocol-defined criteria for IBS-C, including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria;
* Demonstrates English fluency and has access to a touch-tone telephone.
Exclusion Criteria
* Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study;
* Clinically-significant alarm symptoms;
* Secondary causes of constipation or evacuation disorders;
* Surgery to the gastrointestinal tract;
* Usage of prohibited medications.
18 Years
ALL
No
Sponsors
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Ironwood Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Microbia Medical Director, MD
Role: STUDY_DIRECTOR
Microbia, Inc.
Locations
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Microbia Investigational Site
Huntsville, Alabama, United States
Microbia Investigational Site
Chandler, Arizona, United States
Microbia Investigational Site
Tuscon, Arizona, United States
Microbia Investigational Site
Sherwood, Arkansas, United States
Microbia Investigational Site
Anaheim, California, United States
Microbia Investigational Site
Garden Grove, California, United States
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Sacramento, California, United States
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San Diego, California, United States
Microbia Investigational Site
Bristol, Connecticut, United States
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Boynton Beach, Florida, United States
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Dunedin, Florida, United States
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Largo, Florida, United States
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Ocala, Florida, United States
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Port Orange, Florida, United States
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Stuart, Florida, United States
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Tampa, Florida, United States
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Stockbridge, Georgia, United States
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Libertyville, Illinois, United States
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Peoria, Illinois, United States
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Clive, Iowa, United States
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Davenport, Iowa, United States
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Mission, Kansas, United States
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Shawnee, Kansas, United States
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Baton Rouge, Louisiana, United States
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Monroe, Louisiana, United States
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West Monroe, Louisiana, United States
Microbia Investigational Site
Annapolis, Maryland, United States
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Silver Spring, Maryland, United States
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Fall River, Massachusetts, United States
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Ann Arbor, Michigan, United States
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St Louis, Missouri, United States
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Missoula, Montana, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Blackwood, New Jersey, United States
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Great Neck, New York, United States
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Pittsford, New York, United States
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Asheville, North Carolina, United States
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Chapel Hill, North Carolina, United States
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Elkin, North Carolina, United States
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Greensboro, North Carolina, United States
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Harrisburg, North Carolina, United States
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Hickory, North Carolina, United States
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Raleigh, North Carolina, United States
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Statesville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Sylvania, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Yukon, Oklahoma, United States
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Medford, Oregon, United States
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Levittown, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Reading, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Anderson, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Simpsonville, South Carolina, United States
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Summerville, South Carolina, United States
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Bristol, Tennessee, United States
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Germantown, Tennessee, United States
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Jackson, Tennessee, United States
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Kingsport, Tennessee, United States
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Beaumont, Texas, United States
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Corsicana, Texas, United States
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El Paso, Texas, United States
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San Antonio, Texas, United States
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Ogden, Utah, United States
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Chesapeake, Virginia, United States
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Lynchburg, Virginia, United States
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Richmond, Virginia, United States
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Lakewood, Washington, United States
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Olympia, Washington, United States
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Vancouver, Washington, United States
Microbia Investigational Site
Charleston, West Virginia, United States
Microbia Investigational Site
La Crosse, Wisconsin, United States
Microbia Investigational Site
Abbortsford, British Columbia, Canada
Microbia Investigational Site
Winnipeg, Manitoba, Canada
Microbia Investigational Site
Guelph, Ontario, Canada
Microbia Investigational Site
Milton, Ontario, Canada
Microbia Investigational Site
Toronto, Ontario, Canada
Microbia Investigational Site
Saskatoon, Saskatchewan, Canada
Countries
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References
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Lembo A, Kuo B, Boinpally R, Li E, Mallick M, Bochenek W, Bartolini W. Randomised clinical trial: effects of MD-7246 on irritable bowel syndrome with diarrhoea. Aliment Pharmacol Ther. 2023 Jan;57(2):192-204. doi: 10.1111/apt.17274. Epub 2022 Nov 2.
Johnston JM, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, O'Dea C, Baird M, Lembo AJ. Linaclotide improves abdominal pain and bowel habits in a phase IIb study of patients with irritable bowel syndrome with constipation. Gastroenterology. 2010 Dec;139(6):1877-1886.e2. doi: 10.1053/j.gastro.2010.08.041. Epub 2010 Aug 27.
Other Identifiers
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MCP-103-202
Identifier Type: -
Identifier Source: org_study_id
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