An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

Phase 3

Completed

Conditions: Chronic Constipation
Irritable Bowel Syndrome With Constipation

Interventions: Drug: Linaclotide

Registration Number: NCT00765999

Lead Sponsor: Forest Laboratories

Brief Summary: The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1559

Inclusion Criteria

Patients must have
- 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 must not use protocol-defined prohibited medicine
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Linaclotide	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)	Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs.	An AE is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of open-label study medication in this study or was present at, or before, the day of the first dose of open-label study medication in this study and increased in severity during the treatment period. AEs included abnormal clinically significant findings for clinical laboratory tests, physical examination findings, vital sign measurements and electrocardiograms (ECGs).

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (109): Clinical Trials Management of Boca Raton, Inc.
🇺🇸
Boca Raton, Florida, United States
Gastrointestinal Specialists of Georgia, PC
🇺🇸
Marietta, Georgia, United States
Atlanta Gastroenterology Associates, LLC
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Marietta, Georgia, United States
Rosemark WomenCare Specialist
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Idaho Falls, Idaho, United States
Meritus Center for Clinical Research
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Hagerstown, Maryland, United States
Long Island Gastrointestinal Research Group
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Great Neck, New York, United States
Axis Clinical Trials
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Los Angeles, California, United States
Clinical Trials Research Services, LLC
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Pittsburgh, Pennsylvania, United States
Providence Clinical Research
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Burbank, California, United States
Pivotal Research Centers
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Peoria, Arizona, United States
Radiant Research, Inc.
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Lakewood, Washington, United States
Pivotal Research Center
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Peoria, Arizona, United States
LeBauer Research Associates, P.A.
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Greensboro, North Carolina, United States
Heartland Research Associates, LLC
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Wichita, Kansas, United States
Rapid Medical Research, Inc.
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Cleveland, Ohio, United States
St. Louis Center for Clinical Research
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Saint Louis, Missouri, United States
Lifeline Research Institute
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Brooklyn, New York, United States
The Gastroenterology Group of S.J.
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Vineland, New Jersey, United States
Wake Research Associates, LLC
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Raleigh, North Carolina, United States
New Mexico Clinical Research and Osteoporosis Center
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Albuquerque, New Mexico, United States
Cumberland Research Associates, LLC
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Fayetteville, North Carolina, United States
Gastrointestinal Research Associates, LLC
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Setauket, New York, United States
Remington Davis
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Columbus, Ohio, United States
MediSpect, LLC
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Boone, North Carolina, United States
Research Across America RHD Professional Plaza IV
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Dallas, Texas, United States
Wenatchee Valley Medical Center Clinical Research Dept.
🇺🇸
Wenatchee, Washington, United States
PrimeHealth Clinical Research
🇨🇦
Toronto, Ontario, Canada
Meadowlands Family Health Center
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Ottawa, Ontario, Canada
GI Research Institute
🇨🇦
Vancouver, British Columbia, Canada
Mountain View Clinical Research
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Greer, South Carolina, United States
Toronto Digestive Disease Associates, Inc.
🇨🇦
Vaughan, Ontario, Canada
National Clinical Research-Richmond, Inc.
🇺🇸
Richmond, Virginia, United States
Medicor Research, Inc.
🇨🇦
Sudbury, Ontario, Canada
Professional Quality Research, Inc.
🇺🇸
Austin, Texas, United States
London Road Diagnostic Clinic and Medical Center
🇨🇦
Sarnia, Ontario, Canada
Pharmax Research Clinic
🇺🇸
Miami, Florida, United States
Boston Clinical Trials
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Boston, Massachusetts, United States
Consultants for Clinical Research
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Cincinnati, Ohio, United States
Houston Digestive Diseases Clinic
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Houston, Texas, United States
Houston Medical Research Associates
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Houston, Texas, United States
Quality Research Inc.
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San Antonio, Texas, United States
Diagnostics Research Group
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San Antonio, Texas, United States
New River Valley Research Institute
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Christiansburg, Virginia, United States
Innovative Clinical Trials
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Birmingham, Alabama, United States
Parkway Medical Center
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Birmingham, Alabama, United States
Carl T Hayden VA Medical Center GI Section-CS-111G
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Phoenix, Arizona, United States
Elite Clinical Studies, LLC
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Phoenix, Arizona, United States
Colorado Gastroenterology, Prof LLC
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Denver, Colorado, United States
Oklahoma Foundation for Digestive Research
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Oklahoma City, Oklahoma, United States
Nashville Medical Research Institute
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Nashville, Tennessee, United States
Fatigue Consultation Clinic
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Salt Lake City, Utah, United States
Department of Gastroenterology University of Utah Hospital
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Salt Lake City, Utah, United States
Department of Veterans Affairs Research Department
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Salt Lake City, Utah, United States
Medical Affiliated Research Center, Inc.
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Huntsville, Alabama, United States
Genova Clinical Research, Inc.
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Tucson, Arizona, United States
Adobe Clinical Research, LLC
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Tucson, Arizona, United States
Family Medical Center
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Foothill Ranch, California, United States
Facey Medical Foundation
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Mission Hills, California, United States
Advanced Clinical Research Institute
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Orange, California, United States
Encompass Clinical Research North Coast
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Encinitas, California, United States
Westlake Medical Research
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Westlake Village, California, United States
Boulder Medical Center, P.C.
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Boulder, Colorado, United States
Western States Clinical Research
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Wheat Ridge, Colorado, United States
Longmont Medical Research Network
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Longmont, Colorado, United States
Lynn Institute of the Rockies
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Colorado Springs, Colorado, United States
Chase Medical Research, LLC
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Waterbury, Connecticut, United States
PAB Clinical Research
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Brandon, Florida, United States
Meridien Research
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Tampa, Florida, United States
Clinical Physiology Associates Clinical Study Center
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Fort Myers, Florida, United States
University Clinical Research, Inc.
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Pembroke Pines, Florida, United States
Jupiter Research, Inc.
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Jupiter, Florida, United States
United Medical Research
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New Smyrna Beach, Florida, United States
RenStar Medical Research
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Ocala, Florida, United States
FPA Clinical Research
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Kissimmee, Florida, United States
Florida Medical Clinic, P.A. Clinical Research Division
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Zephyrhills, Florida, United States
Compass Research
🇺🇸
Orlando, Florida, United States
Advanced Research Institute
🇺🇸
Trinity, Florida, United States
Emerald Coast Research Associates
🇺🇸
Panama City, Florida, United States
Miami Research Associates
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South Miami, Florida, United States
North Georgia Clinical Research
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Woodstock, Georgia, United States
Central Kentucky Research Associates
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Lexington, Kentucky, United States
Clinical Research Atlanta
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Stockbridge, Georgia, United States
University of Iowa Hospitals & Clinics
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Iowa City, Iowa, United States
Rockford Gastroenterology Associates, Ltd.
🇺🇸
Rockford, Illinois, United States
MediSphere Medical Research Center, LLC
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Evansville, Indiana, United States
Clinical Trials of America, Inc.
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Shreveport, Louisiana, United States
Medical Development Centers, LLC
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Baton Rouge, Louisiana, United States
Trover Health System
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Madisonville, Kentucky, United States
Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
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Chevy Chase, Maryland, United States
Kalamazoo Gastroenterology Hepatology
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Kalamazoo, Michigan, United States
Ridgeview Research Two Twelve Medical Center
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Chaska, Minnesota, United States
Charm City Research
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Towson, Maryland, United States
Long Island Clinical Research Associates, LLP
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Great Neck, New York, United States
Clinical Trials of America, INC
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Hickory, North Carolina, United States
Gastroenterology United of Tulsa
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Tulsa, Oklahoma, United States
Digestive Health Specialists, PA
🇺🇸
Winston-Salem, North Carolina, United States
Hometown Urgent Care and Research
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Dayton, Ohio, United States
Upstate Pharmaceutical Research
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Greenville, South Carolina, United States
R/D Clinical Research, Inc.
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Lake Jackson, Texas, United States
Charlottesville Medical Research
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Charlottesville, Virginia, United States
Clinical Research Associates of Tidewater
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Norfolk, Virginia, United States
Health Research of Hampton Roads
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Newport News, Virginia, United States
National Clinical Research - Norfolk, Inc.
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Norfolk, Virginia, United States
Northwest Gastroenterology Associates
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Bellevue, Washington, United States
Aurora Advanced Healthcare, Inc. Clinical Research Center
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Milwaukee, Wisconsin, United States
MedPhase Canada
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Newmarket, Ontario, Canada
St. Joseph Healthcare
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Hamilton, Ontario, Canada
Hanover Medical Specialists, PA
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Wilmington, North Carolina, United States
Radiant Research
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Greer, South Carolina, United States