An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
NCT ID: NCT00730171
Last Updated: 2018-02-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1743 participants
INTERVENTIONAL
2008-09-30
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Linaclotide
Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.
Linaclotide
Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.
Interventions
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Linaclotide
Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* entered study MCP-103-303 or MCP-103-302 and at minimum completed the pre-treatment period or
* completed one of the following studies: MCP-103-004, MCP-103-005, MCP-103-201, MCP-103-202
* Sexually active patients of childbearing potential agree to use birth control
* Females of childbearing potential must have a negative urine pregnancy test prior to dosing
* Lactating females must agree not to breastfeed
* Patient must meet protocol criteria for CC or IBS-C
Exclusion Criteria
* Patient is planning to receive an investigational drug at any time during the study
* Patient has an unresolved adverse events or a clinically significant finding on a physical examination, 12-lead electrocardiogram, or clinical laboratory test
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
Ironwood Investigational Site
Phoenix, Arizona, United States
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Tucson, 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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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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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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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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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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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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Huntersville, 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
Ironwood Investigational Site
Summerville, North Carolina, United States
Ironwood Investigational Site
Wilmington, North Carolina, United States
Ironwood Investigational Site
Winston-Salem, North Carolina, United States
Ironwood Investigational Site
Beachwood, Ohio, United States
Ironwood Investigational Site
Cincinnati, Ohio, United States
Ironwood Investigational Site
Cincinnati, Ohio, United States
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Dayton, Ohio, United States
Ironwood Investigational Site
Mentor, 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
Ironwood Investigational Site
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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Sugar Land, 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
Ironwood Investigational Site
Lynchburg, Virginia, United States
Ironwood Investigational Site
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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Other Identifiers
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MCP-103-305
Identifier Type: -
Identifier Source: org_study_id
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