Trial of Linaclotide in Patients With Chronic Constipation
NCT ID: NCT00730015
Last Updated: 2013-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
643 participants
INTERVENTIONAL
2008-08-31
2009-10-31
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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145 μg linaclotide
Linaclotide
Oral, once daily
290 μg linaclotide
Linaclotide
Oral, once daily
Matching Placebo
Matching Placebo
Oral, once daily
Interventions
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Matching Placebo
Oral, once daily
Linaclotide
Oral, once daily
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 CC: reports \< 3 bowel movements per week and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during \> 25% of BMs
* Patient demonstrates continued chronic constipation through Pretreatment Period
* Patient is compliant with IVRS
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
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
Birmingham, Alabama, United States
Ironwood Investigational Site
Huntsville, Alabama, United States
Ironwood Investigational Site
Chandler, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Tuscon, 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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Los Angeles, California, United States
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Orange, California, United States
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Sacramento, 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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Port Orange, 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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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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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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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Cedar Knolls, New Jersey, United States
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Marlton, New Jersey, United States
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Ocean City, New Jersey, United States
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Albuquerque, New Mexico, United States
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Mineola, New York, United States
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Pittsford, New York, 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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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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Jacksonville, 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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Summerville, North Carolina, United States
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Wilmington, 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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Sylvania, Ohio, United States
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Wadsworth, Ohio, United States
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Zanesville, 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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Lancaster, Pennsylvania, United States
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Levittown, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Sellersville, 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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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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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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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
Ironwood Investigational Site
Vancouver, Washington, United States
Ironwood Investigational Site
La Crosse, Wisconsin, United States
Ironwood Investigational Site
Milwaukee, Wisconsin, United States
Countries
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References
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Chang L, Lembo AJ, Lavins BJ, Shiff SJ, Hao X, Chickering JG, Jia XD, Currie MG, Kurtz CB, Johnston JM. The impact of abdominal pain on global measures in patients with chronic idiopathic constipation, before and after treatment with linaclotide: a pooled analysis of two randomised, double-blind, placebo-controlled, phase 3 trials. Aliment Pharmacol Ther. 2014 Dec;40(11-12):1302-12. doi: 10.1111/apt.12985. Epub 2014 Oct 13.
Lembo AJ, Schneier HA, Shiff SJ, Kurtz CB, MacDougall JE, Jia XD, Shao JZ, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Eng P, Fox SM, Johnston JM. Two randomized trials of linaclotide for chronic constipation. N Engl J Med. 2011 Aug 11;365(6):527-36. doi: 10.1056/NEJMoa1010863.
Other Identifiers
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MCP-103-303
Identifier Type: -
Identifier Source: org_study_id
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