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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00765999
Other study ID # LIN-MD-02
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 31, 2008
Est. completion date January 31, 2012

Study information

Verified date January 2019
Source Forest Laboratories
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 1559
Est. completion date January 31, 2012
Est. primary completion date January 31, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Linaclotide
Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Forest Laboratories Ironwood Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) 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). Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs.
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