Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation
NCT ID: NCT00765882
Last Updated: 2013-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
633 participants
INTERVENTIONAL
2008-09-30
2009-08-31
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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1
Linaclotide 290 micrograms
Linaclotide 290 micrograms
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
2
Linaclotide 145 micrograms
Linaclotide 145 micrograms
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
3
Matching placebo
Placebo
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
Interventions
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Linaclotide 290 micrograms
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
Linaclotide 145 micrograms
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
Placebo
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
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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Ironwood Pharmaceuticals, Inc.
INDUSTRY
Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Paul F.C. Eng, PhD
Role: STUDY_DIRECTOR
Forest Laboratories
Locations
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Forest Investigative Site
Birmingham, Alabama, United States
Forest Investigative Site
Birmingham, Alabama, United States
Forest Investigative Site
Huntsville, Alabama, United States
Forest Investigative Site
Chandler, Arizona, United States
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Mesa, Arizona, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Burbank, California, United States
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Encinitas, California, United States
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Foothill Ranch, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Westlake Village, California, United States
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Boulder, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Longmont, Colorado, United States
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Wheat Ridge, Colorado, United States
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Waterbury, Connecticut, United States
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Boca Raton, Florida, United States
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Bradenton, Florida, United States
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Brooksville, Florida, United States
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Fort Myers, Florida, United States
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Jupiter, Florida, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Panama City, Florida, United States
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Pembroke Pines, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Trinity, Florida, United States
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Zephyrhills, Florida, United States
Forest Investigative Site
Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Marietta, Georgia, United States
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Stockbridge, Georgia, United States
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Woodstock, Georgia, United States
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Idaho Falls, Idaho, United States
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Rockford, Illinois, United States
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Elkhart, Indiana, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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Arkansas City, Kansas, United States
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Newton, Kansas, United States
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Wichita, Kansas, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Madisonville, Kentucky, United States
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Chevy Chase, Maryland, United States
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Hagerstown, Maryland, United States
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Lutherville, Maryland, United States
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Boston, Massachusetts, United States
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Chaska, Minnesota, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Vineland, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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Great Neck, New York, United States
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Great Neck, New York, United States
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Fayetteville, North Carolina, United States
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Greensboro, North Carolina, United States
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Hickory, North Carolina, United States
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Raleigh, North Carolina, United States
Forest Investigative Site
Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Bismarck, North Dakota, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Bensalem, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Greenville, South Carolina, United States
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Greer, South Carolina, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Lake Jackson, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
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Christianburg, Virginia, United States
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Newport News, Virginia, United States
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Norfolk, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Bellevue, Washington, United States
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Lakewood, Washington, United States
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Wenatchee, Washington, United States
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Milwaukee, Wisconsin, United States
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Vancouver, British Columbia, Canada
Forest Investigative Site
Greater Sudbury, Ontario, Canada
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Hamilton, Ontario, Canada
Forest Investigative Site
Newmarket, Ontario, Canada
Forest Investigative Site
Ottawa, Ontario, Canada
Forest Investigative Site 1
Sarnia, Ontario, Canada
Forest Investigative Site 2
Sarnia, Ontario, Canada
Forest Investigative Site
Toronto, Ontario, Canada
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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LIN-MD-01
Identifier Type: -
Identifier Source: org_study_id
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