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

Last updated: January 24, 2019
Sponsor: Forest Laboratories
Overall Status: Completed

Phase

3

Condition

Constipation

Colic

Lactose Intolerance

Treatment

N/A

Clinical Study ID

NCT00765999
LIN-MD-02
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must have

  • entered study LIN-MD 01[NCT00765882] or LIN-MD-31 [NCT00948818] and at minimumcompleted 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 todosing

  • Lactating females must agree not to breastfeed

  • Patient must meet protocol criteria for CC or IBS-C

Exclusion

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 physicalexamination, 12-lead ECG, or clinical laboratory test

Study Design

Total Participants: 1559
Study Start date:
October 31, 2008
Estimated Completion Date:
January 31, 2012

Connect with a study center

  • GI Research Institute

    Vancouver, British Columbia V6Z 2K5
    Canada

    Site Not Available

  • St. Joseph Healthcare

    Hamilton, Ontario L8N 4A6
    Canada

    Site Not Available

  • MedPhase Canada

    Newmarket, Ontario L3Y 8E4
    Canada

    Site Not Available

  • Meadowlands Family Health Center

    Ottawa, Ontario K2C 3R2
    Canada

    Site Not Available

  • London Road Diagnostic Clinic and Medical Center

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • Medicor Research, Inc.

    Sudbury, Ontario P3E 1H5
    Canada

    Site Not Available

  • PrimeHealth Clinical Research

    Toronto, Ontario M4S 1Y2
    Canada

    Site Not Available

  • Toronto Digestive Disease Associates, Inc.

    Vaughan, Ontario L4L 4Y7
    Canada

    Site Not Available

  • Innovative Clinical Trials

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Parkway Medical Center

    Birmingham, Alabama 35215
    United States

    Site Not Available

  • Medical Affiliated Research Center, Inc.

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Radiant Research, Inc.

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Forest Investigative Site 053

    Mesa, Arizona 85210
    United States

    Site Not Available

  • Pivotal Research Center

    Peoria, Arizona 85381
    United States

    Site Not Available

  • Pivotal Research Centers

    Peoria, Arizona 85381
    United States

    Site Not Available

  • Carl T Hayden VA Medical Center GI Section-CS-111G

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Elite Clinical Studies, LLC

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Radiant Research, Inc.

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Adobe Clinical Research, LLC

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Genova Clinical Research, Inc.

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Providence Clinical Research

    Burbank, California 91505
    United States

    Site Not Available

  • Encompass Clinical Research North Coast

    Encinitas, California 92024
    United States

    Site Not Available

  • Family Medical Center

    Foothill Ranch, California 92610
    United States

    Site Not Available

  • Axis Clinical Trials

    Los Angeles, California 90036
    United States

    Site Not Available

  • Facey Medical Foundation

    Mission Hills, California 91345
    United States

    Site Not Available

  • Advanced Clinical Research Institute

    Orange, California 92869
    United States

    Site Not Available

  • Westlake Medical Research

    Westlake Village, California 91361
    United States

    Site Not Available

  • Boulder Medical Center, P.C.

    Boulder, Colorado 80304
    United States

    Site Not Available

  • Lynn Institute of the Rockies

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Colorado Gastroenterology, Prof LLC

    Denver, Colorado 80205
    United States

    Site Not Available

  • Longmont Medical Research Network

    Longmont, Colorado 80501
    United States

    Site Not Available

  • Western States Clinical Research

    Wheat Ridge, Colorado 80033
    United States

    Site Not Available

  • Chase Medical Research, LLC

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Clinical Trials Management of Boca Raton, Inc.

    Boca Raton, Florida 33428
    United States

    Site Not Available

  • Meridien Research

    Bradenton, Florida 34208
    United States

    Site Not Available

  • PAB Clinical Research

    Brandon, Florida 33511
    United States

    Site Not Available

  • Meridien Research

    Brooksville, Florida 34601
    United States

    Site Not Available

  • Clinical Physiology Associates Clinical Study Center

    Fort Myers, Florida 33916
    United States

    Site Not Available

  • Forest Investigative Site 018

    Ft. Myers, Florida 33916
    United States

    Site Not Available

  • Jupiter Research, Inc.

    Jupiter, Florida 33458
    United States

    Site Not Available

  • FPA Clinical Research

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Pharmax Research Clinic

    Miami, Florida 33126
    United States

    Site Not Available

  • United Medical Research

    New Smyrna Beach, Florida 32168
    United States

    Site Not Available

  • RenStar Medical Research

    Ocala, Florida 34471
    United States

    Site Not Available

  • Compass Research

    Orlando, Florida 32806
    United States

    Site Not Available

  • Emerald Coast Research Associates

    Panama City, Florida 32405
    United States

    Site Not Available

  • University Clinical Research, Inc.

    Pembroke Pines, Florida 33024
    United States

    Site Not Available

  • Meridien Research

    Saint Petersburg, Florida 33709
    United States

    Site Not Available

  • Miami Research Associates

    South Miami, Florida 33143
    United States

    Site Not Available

  • Forest Investigative Site 045

    St. Petersburg, Florida 33709
    United States

    Site Not Available

  • Meridien Research

    Tampa, Florida 33606
    United States

    Site Not Available

  • Advanced Research Institute

    Trinity, Florida 34655
    United States

    Site Not Available

  • Florida Medical Clinic, P.A. Clinical Research Division

    Zephyrhills, Florida 33542
    United States

    Site Not Available

  • Radiant Research, Inc.

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Atlanta Gastroenterology Associates, LLC

    Marietta, Georgia 30067
    United States

    Site Not Available

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Clinical Research Atlanta

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • North Georgia Clinical Research

    Woodstock, Georgia 30189
    United States

    Site Not Available

  • Rosemark WomenCare Specialist

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Rockford Gastroenterology Associates, Ltd.

    Rockford, Illinois 61107
    United States

    Site Not Available

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana 47714
    United States

    Site Not Available

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Heartland Research Associates, LLC

    Arkansas City, Kansas 67005
    United States

    Site Not Available

  • Heartland Research Associates, LLC

    Newton, Kansas 67114
    United States

    Site Not Available

  • Heartland Research Associates, LLC

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Central Kentucky Research Associates

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Trover Health System

    Madisonville, Kentucky 42431
    United States

    Site Not Available

  • Medical Development Centers, LLC

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Clinical Trials of America, Inc.

    Shreveport, Louisiana 71101
    United States

    Site Not Available

  • Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Meritus Center for Clinical Research

    Hagerstown, Maryland 21742
    United States

    Site Not Available

  • Forest Investigative Site 073

    Lutherville, Maryland 21093
    United States

    Site Not Available

  • Charm City Research

    Towson, Maryland 21286
    United States

    Site Not Available

  • Boston Clinical Trials

    Boston, Massachusetts 02135
    United States

    Site Not Available

  • Kalamazoo Gastroenterology Hepatology

    Kalamazoo, Michigan 49048
    United States

    Site Not Available

  • Ridgeview Research Two Twelve Medical Center

    Chaska, Minnesota 55318
    United States

    Site Not Available

  • St. Louis Center for Clinical Research

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • Forest Investigative Site 004

    St. Louis, Missouri 63128
    United States

    Site Not Available

  • The Gastroenterology Group of S.J.

    Vineland, New Jersey 08360
    United States

    Site Not Available

  • New Mexico Clinical Research and Osteoporosis Center

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • Lifeline Research Institute

    Brooklyn, New York 11214
    United States

    Site Not Available

  • Long Island Clinical Research Associates, LLP

    Great Neck, New York 11021
    United States

    Site Not Available

  • Long Island Gastrointestinal Research Group

    Great Neck, New York 11023
    United States

    Site Not Available

  • Gastrointestinal Research Associates, LLC

    Setauket, New York 11733
    United States

    Site Not Available

  • MediSpect, LLC

    Boone, North Carolina 28607
    United States

    Site Not Available

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • LeBauer Research Associates, P.A.

    Greensboro, North Carolina 27403
    United States

    Site Not Available

  • Clinical Trials of America, INC

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • Wake Research Associates, LLC

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Hanover Medical Specialists, PA

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Digestive Health Specialists, PA

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Consultants for Clinical Research

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Rapid Medical Research, Inc.

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Remington Davis

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Hometown Urgent Care and Research

    Dayton, Ohio 45432
    United States

    Site Not Available

  • Oklahoma Foundation for Digestive Research

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Gastroenterology United of Tulsa

    Tulsa, Oklahoma 74135
    United States

    Site Not Available

  • Clinical Trials Research Services, LLC

    Pittsburgh, Pennsylvania 15206
    United States

    Site Not Available

  • Upstate Pharmaceutical Research

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Mountain View Clinical Research

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Radiant Research

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Nashville Medical Research Institute

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Professional Quality Research, Inc.

    Austin, Texas 78705
    United States

    Site Not Available

  • Research Across America RHD Professional Plaza IV

    Dallas, Texas 75234
    United States

    Site Not Available

  • Houston Digestive Diseases Clinic

    Houston, Texas 77090
    United States

    Site Not Available

  • Houston Medical Research Associates

    Houston, Texas 77090
    United States

    Site Not Available

  • R/D Clinical Research, Inc.

    Lake Jackson, Texas 77566
    United States

    Site Not Available

  • Diagnostics Research Group

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Quality Research Inc.

    San Antonio, Texas 78209
    United States

    Site Not Available

  • Department of Gastroenterology University of Utah Hospital

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Department of Veterans Affairs Research Department

    Salt Lake City, Utah 84148
    United States

    Site Not Available

  • Fatigue Consultation Clinic

    Salt Lake City, Utah 84102
    United States

    Site Not Available

  • Charlottesville Medical Research

    Charlottesville, Virginia 22911
    United States

    Site Not Available

  • Forest Investigative Site 061

    Christianburg, Virginia 24073
    United States

    Site Not Available

  • New River Valley Research Institute

    Christiansburg, Virginia 24073
    United States

    Site Not Available

  • Health Research of Hampton Roads

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • National Clinical Research - Norfolk, Inc.

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • National Clinical Research-Richmond, Inc.

    Richmond, Virginia 23294
    United States

    Site Not Available

  • Northwest Gastroenterology Associates

    Bellevue, Washington 98004
    United States

    Site Not Available

  • Radiant Research, Inc.

    Lakewood, Washington 98499
    United States

    Site Not Available

  • Wenatchee Valley Medical Center Clinical Research Dept.

    Wenatchee, Washington 98801
    United States

    Site Not Available

  • Aurora Advanced Healthcare, Inc. Clinical Research Center

    Milwaukee, Wisconsin 53209
    United States

    Site Not Available

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