Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT ID: NCT00938717
Last Updated: 2013-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
805 participants
INTERVENTIONAL
2009-07-31
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Linaclotide or Matching Placebo
Linaclotide or Matching Placebo, administered orally, once daily, for the duration of the trial
290 μg Linaclotide
Linaclotide or Matching Placebo
Linaclotide or Matching Placebo, administered orally, once daily, for the duration of the trial
Interventions
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Linaclotide or Matching Placebo
Linaclotide or Matching Placebo, administered orally, once daily, for the duration of the trial
Eligibility Criteria
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Inclusion Criteria
* Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests
* Patient meets protocol criteria for diagnosis of IBS-C
* Patient demonstrates continued IBS-C through Pretreatment Period
* Patient is compliant with IVRS
Exclusion Criteria
* 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
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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Jeffrey M. Johnston, MD, FACP
Role: STUDY_CHAIR
Ironwood Pharmaceuticals, Inc.
Locations
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Ironwood Investigational Site
Mineola, New York, United States
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Pittsford, New York, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Phoenix, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Sherwood, Arkansas, United States
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Anaheim, California, United States
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Chula Vista, California, United States
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Encinitas, California, United States
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Garden Grove, California, United States
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Laguna Hills, California, United States
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Orange, California, United States
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San Carlos, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Colorado Springs, Colorado, United States
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Bristol, Connecticut, United States
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Boynton Beach, Florida, United States
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Hollywood, Florida, United States
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Inverness, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Lauderdale Lakes, Florida, United States
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Miami, Florida, United States
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Pinellas Park, Florida, United States
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Tampa, Florida, United States
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Newnan, Georgia, United States
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Peoria, Illinois, United States
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Anderson, Indiana, 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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Overland Park, Kansas, United States
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Topeka, Kansas, United States
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Baton Rouge, Louisiana, United States
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Metairie, Louisiana, United States
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Monroe, Louisiana, United States
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Shreveport, Louisiana, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Hollywood, Maryland, United States
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Laurel, Maryland, United States
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Chesterfield, Michigan, United States
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Traverse City, Michigan, United States
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Troy, Michigan, United States
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Plymouth, Minnesota, United States
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Jackson, Mississippi, United States
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Tupelo, Mississippi, United States
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Jefferson City, Missouri, United States
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Marlton, New Jersey, United States
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Albuquerque, New Mexico, United States
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Asheboro, North Carolina, 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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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Greensboro, 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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Huntersville, North Carolina, United States
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New Bern, 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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Beachwood, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Mentor, Ohio, United States
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Sylvania, Ohio, United States
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Wadsworth, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Yukon, Oklahoma, United States
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Lancaster, Pennsylvania, United States
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Levittown, Pennsylvania, United States
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Reading, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Washington, Pennsylvania, United States
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Anderson, South Carolina, United States
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Charleston, 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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Chattanooga, Tennessee, United States
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Germantown, Tennessee, United States
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Kingsport, Tennessee, United States
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Nashville, Tennessee, United States
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Beaumont, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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Longview, Texas, United States
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San Antonio, Texas, United States
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Sugarland, Texas, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Chesapeake, Virginia, United States
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Lynchburg, Virginia, United States
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Spokane, Washington, United States
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Vancouver, Washington, United States
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La Crosse, Wisconsin, United States
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Milwaukee, Wisconsin, United States
Countries
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References
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Rao SS, Quigley EM, Shiff SJ, Lavins BJ, Kurtz CB, MacDougall JE, Currie MG, Johnston JM. Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation. Clin Gastroenterol Hepatol. 2014 Apr;12(4):616-23. doi: 10.1016/j.cgh.2013.09.022. Epub 2013 Sep 25.
Quigley EM, Tack J, Chey WD, Rao SS, Fortea J, Falques M, Diaz C, Shiff SJ, Currie MG, Johnston JM. Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints. Aliment Pharmacol Ther. 2013 Jan;37(1):49-61. doi: 10.1111/apt.12123. Epub 2012 Nov 1.
Other Identifiers
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MCP-103-302
Identifier Type: -
Identifier Source: org_study_id