An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
NCT ID: NCT00765999
Last Updated: 2019-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1559 participants
INTERVENTIONAL
2008-10-31
2012-01-31
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 in participants with either CC or IBS-C. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.
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 LIN-MD 01\[NCT00765882\] or LIN-MD-31 \[NCT00948818\] and at minimum completed the pre-treatment period or
* completed one of the following studies: MCP-103-004 \[NCT00306748\], MCP-103-005 \[NCT00258193\], MCP-103-201 \[NCT00402337\], MCP-103-202 \[NCT00460811\]
* 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 AE or a clinically significant finding on a physical examination, 12-lead ECG, or clinical laboratory test
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 Eng, PhD
Role: STUDY_DIRECTOR
Forest Laboratories
Locations
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Innovative Clinical Trials
Birmingham, Alabama, United States
Parkway Medical Center
Birmingham, Alabama, United States
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States
Radiant Research, Inc.
Chandler, Arizona, United States
Pivotal Research Centers
Peoria, Arizona, United States
Pivotal Research Center
Peoria, Arizona, United States
Carl T Hayden VA Medical Center GI Section-CS-111G
Phoenix, Arizona, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
Radiant Research, Inc.
Scottsdale, Arizona, United States
Genova Clinical Research, Inc.
Tucson, Arizona, United States
Adobe Clinical Research, LLC
Tucson, Arizona, United States
Providence Clinical Research
Burbank, California, United States
Encompass Clinical Research North Coast
Encinitas, California, United States
Family Medical Center
Foothill Ranch, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Facey Medical Foundation
Mission Hills, California, United States
Advanced Clinical Research Institute
Orange, California, United States
Westlake Medical Research
Westlake Village, California, United States
Boulder Medical Center, P.C.
Boulder, Colorado, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States
Colorado Gastroenterology, Prof LLC
Denver, Colorado, United States
Longmont Medical Research Network
Longmont, Colorado, United States
Western States Clinical Research
Wheat Ridge, Colorado, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Clinical Trials Management of Boca Raton, Inc.
Boca Raton, Florida, United States
Meridien Research
Bradenton, Florida, United States
PAB Clinical Research
Brandon, Florida, United States
Meridien Research
Brooksville, Florida, United States
Clinical Physiology Associates Clinical Study Center
Fort Myers, Florida, United States
Jupiter Research, Inc.
Jupiter, Florida, United States
FPA Clinical Research
Kissimmee, Florida, United States
Pharmax Research Clinic
Miami, Florida, United States
United Medical Research
New Smyrna Beach, Florida, United States
RenStar Medical Research
Ocala, Florida, United States
Compass Research
Orlando, Florida, United States
Emerald Coast Research Associates
Panama City, Florida, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Meridien Research
Tampa, Florida, United States
Advanced Research Institute
Trinity, Florida, United States
Florida Medical Clinic, P.A. Clinical Research Division
Zephyrhills, Florida, United States
Radiant Research, Inc.
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Atlanta Gastroenterology Associates, LLC
Marietta, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
Rosemark WomenCare Specialist
Idaho Falls, Idaho, United States
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Heartland Research Associates, LLC
Arkansas City, Kansas, United States
Heartland Research Associates, LLC
Newton, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Central Kentucky Research Associates
Lexington, Kentucky, United States
Trover Health System
Madisonville, Kentucky, United States
Medical Development Centers, LLC
Baton Rouge, Louisiana, United States
Clinical Trials of America, Inc.
Shreveport, Louisiana, United States
Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, United States
Charm City Research
Towson, Maryland, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Kalamazoo Gastroenterology Hepatology
Kalamazoo, Michigan, United States
Ridgeview Research Two Twelve Medical Center
Chaska, Minnesota, United States
St. Louis Center for Clinical Research
St Louis, Missouri, United States
The Gastroenterology Group of S.J.
Vineland, New Jersey, United States
New Mexico Clinical Research and Osteoporosis Center
Albuquerque, New Mexico, United States
Lifeline Research Institute
Brooklyn, New York, United States
Long Island Clinical Research Associates, LLP
Great Neck, New York, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, United States
Gastrointestinal Research Associates, LLC
Setauket, New York, United States
MediSpect, LLC
Boone, North Carolina, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States
LeBauer Research Associates, P.A.
Greensboro, North Carolina, United States
Clinical Trials of America, INC
Hickory, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Hanover Medical Specialists, PA
Wilmington, North Carolina, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, United States
Remington Davis
Columbus, Ohio, United States
Hometown Urgent Care and Research
Dayton, Ohio, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
Gastroenterology United of Tulsa
Tulsa, Oklahoma, United States
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, United States
Upstate Pharmaceutical Research
Greenville, South Carolina, United States
Mountain View Clinical Research
Greer, South Carolina, United States
Radiant Research
Greer, South Carolina, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
Professional Quality Research, Inc.
Austin, Texas, United States
Research Across America RHD Professional Plaza IV
Dallas, Texas, United States
Houston Digestive Diseases Clinic
Houston, Texas, United States
Houston Medical Research Associates
Houston, Texas, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States
Quality Research Inc.
San Antonio, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
Fatigue Consultation Clinic
Salt Lake City, Utah, United States
Department of Gastroenterology University of Utah Hospital
Salt Lake City, Utah, United States
Department of Veterans Affairs Research Department
Salt Lake City, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
New River Valley Research Institute
Christiansburg, Virginia, United States
Health Research of Hampton Roads
Newport News, Virginia, United States
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
National Clinical Research-Richmond, Inc.
Richmond, Virginia, United States
Northwest Gastroenterology Associates
Bellevue, Washington, United States
Radiant Research, Inc.
Lakewood, Washington, United States
Wenatchee Valley Medical Center Clinical Research Dept.
Wenatchee, Washington, United States
Aurora Advanced Healthcare, Inc. Clinical Research Center
Milwaukee, Wisconsin, United States
GI Research Institute
Vancouver, British Columbia, Canada
Medicor Research, Inc.
Greater Sudbury, Ontario, Canada
St. Joseph Healthcare
Hamilton, Ontario, Canada
MedPhase Canada
Newmarket, Ontario, Canada
Meadowlands Family Health Center
Ottawa, Ontario, Canada
London Road Diagnostic Clinic and Medical Center
Sarnia, Ontario, Canada
PrimeHealth Clinical Research
Toronto, Ontario, Canada
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, Canada
Countries
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Other Identifiers
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LIN-MD-02
Identifier Type: -
Identifier Source: org_study_id
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