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



Status:Completed
Conditions:Constipation, Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:October 31, 2008
End Date:January 31, 2012

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Trial Summary
Trial Overview
Inclusion Criteria

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

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).


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
We found this trial at
110
sites
Emerald Coast Research Associates
221 East 23rd
Panama City, Florida 32405
850-785-6550
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Clinical Trials Management of Boca Raton, Inc.
5458 Town Center Rd # 19
Boca Raton, Florida 33486
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Upstate Pharmaceutical Research
30 Pointe Circle
Greenville, South Carolina 29615
(864)255-3540
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Medical Affiliated Research Center, Inc.
303 Williams Ave
Huntsville, Alabama 35801
256-533-6603
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Jupiter Research
875 Military Trl # 210
Jupiter, Florida 33458
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Longmont Medical Research Network
1925 W. Mountain View Ave.
Longmont, Colorado 80501
303-776-8718
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Clinical Research Associates of Tidewater
400 Gresham Dr
Norfolk, Virginia 23507
757-627-7446
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Norfolk, VA
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Renstar Medical Research
104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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Compass Research LLC
100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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Rockford Gastroenterology Associates, Ltd.
401 Roxbury Road
Rockford, Illinois 61107
815-397-7340
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Rockford, IL
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Diagnostics Research Group
4410 Medical Drive
San Antonio, Texas 78229
210-692-7157
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Miami Research Associates
6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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Genova Clinical Research
6261 N. La Cholla Blvd
Tucson, Arizona 85741
520-219-6394
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Chase Medical Research, LLC
500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
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Heartland Research Associates, LLC
1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico 87106
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Heartland Research Associates LLC
Arkansas City, Kansas 67005
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Radiant Research, Inc.
Atlanta, Georgia
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Professional Quality Research, Inc.
Austin, Texas 78705
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Medical Development Centers, Llc
Baton Rouge, Louisiana 70808
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Northwest Gastroenterology Associates
Bellevue, Washington 98004
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Innovative Clinical Trials
Birmingham, Alabama 35205
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Parkway Medical Center
Birmingham, Alabama 35215
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MediSpect
Boone, North Carolina 28607
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Boston Clinical Trials, INC.
Boston, Massachusetts 02135
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Boulder Medical Center
Boulder, Colorado 80304
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Meridien Research
Bradenton, Florida
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PAB Clinical Research
Brandon, Florida 33511
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LifeLine Research Institute, Inc.
Brooklyn, New York 11214
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Meridien Research
Brooksville, Florida
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Providence Clinical Research
Burbank, California 91505
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Radiant Research
Chandler, Arizona 85225
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Charlottesville Medical Research Inc.
Charlottesville, Virginia 22911
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Ridgeview Research Two Twelve Medical Center
Chaska, Minnesota 55318
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Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
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New River Valley Research Institute
Christiansburg, Virginia 24073
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Consultants for Clinical Research Inc.
Cincinnati, Ohio 45219
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Rapid Medical Research, Inc.
Cleveland, Ohio 44122
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Lynn Institute of the Rockies
Colorado Springs, Colorado 80907
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Remington Davis Inc.
Columbus, Ohio 43215
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Research Across America RHD Professional Plaza IV
Dallas, Texas 75234
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Hometown Urgent Care and Research
Dayton, Ohio 45432
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Colorado Gastroenterology, Prof LLC
Denver, Colorado 80205
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Encompass Clinical Research North Coast
Encinitas, California 92024
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Medisphere Medical Research Center
Evansville, Indiana 47714
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Cumberland Research Associates
Fayetteville, North Carolina 28304
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Family Medical Center
Foothill Ranch, California 92610
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Clinical Physiology Associates Clinical Study Center
Fort Myers, Florida 33912
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Long Island Clinical Research Associates, LLP
Great Neck, New York 11021
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Long Island Gastrointestinal Research Group
Great Neck, New York 11023
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LeBauer Research Associates
Greensboro, North Carolina 27406
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Mountain View Clinical Research
Greer, South Carolina 29651
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Radiant Research
Greer, South Carolina
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Meritus Center For Clinical Research
Hagerstown, Maryland 21740
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Clinical Trials of America Inc
Hickory, North Carolina 28601
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Houston Digestive Diseases Clinic
17070 Red Oak Drive
Houston, Texas 77090
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Houston Medical Research Associates
Houston, Texas 77090
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Rosemark WomenCare Specialist
Idaho Falls, Idaho 83404
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University of Iowa Hospitals and Clinics
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Kalamazoo Gastroenterology Hepatology
Kalamazoo, Michigan 49048
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Fpa Clinical Research
Kissimmee, Florida 34741
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R/D Clinical Research, Inc.
Lake Jackson, Texas 77566
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Radiant Research
Lakewood, Washington 98499
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Central Kentucky Research Associates, Inc.
Lexington, Kentucky 40509
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Axis Clinical Trials
Los Angeles, California 90036
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Trover Health System
Madisonville, Kentucky 42431
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Gastrointestinal Specialists of Georgia
Marietta, Georgia 30060
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Atlanta Gastroenterology Associates, LLC
Marietta, Georgia 30067
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Pharmax Research Clinic
Miami, Florida 33126
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Aurora Advanced Healthcare, Inc-Clinical Research Center
Milwaukee, Wisconsin 53209
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Facey Medical Foundation
Mission Hills, California 91345
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Nashville Medical Research Institute
Nashville, Tennessee 37205
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United Medical Research
New Smyrna Beach, Florida 32168
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Health Research of Hampton Roads
Newport News, Virginia 23606
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Heartland Research Associates
Newton, Kansas 67114
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National Clinical Research - Norfolk, Inc.
Norfolk, Virginia 23502
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Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma 73104
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Advanced Clinical Research Institute
Orange, California 92869
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University Clinical Research, Inc
pembroke Pines, Florida 33024
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Pivotal Research Centers
Peoria, Arizona 85381
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Pivotal Research Center
Peoria, Arizona 85381
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Carl T Hayden VA Medical Center GI Section-CS-111G
Phoenix, Arizona 85012
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Elite Clinical Studies
Phoenix, Arizona 85018
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Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania 15206
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Wake Research Associates, LLC
3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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National Clinical Research - Richmond, Inc.
Richmond, Virginia 23294
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St Louis Center For Clinical Research
Saint Louis, Missouri 63128
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Meridien Research
Saint Petersburg, Florida 33709
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The Fatigue Consultation Clinic
Salt Lake City, Utah 84102
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Department of Gastroenterology University of Utah Hospital
Salt Lake City, Utah 84132
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Department of Veterans Affairs Research Department
Salt Lake City, Utah 84148
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Quality Research
San Antonio, Texas 78209
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Radiant Research
Scottsdale, Arizona 85251
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Gastrointestinal Research Associates
Setauket, New York 11733
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Clinical Trials of America, Inc.
Shreveport, Louisiana 71101
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Clinical Research Atlanta
Stockbridge, Georgia 30281
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Meridien Research
Tampa, Florida
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Charm City Research
Towson, Maryland 21286
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Advanced Research Institute, Inc.
Trinity, Florida 34655
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Adobe Clinical Research, LLC
Tucson, Arizona 85712
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Gastroenterology United of Tulsa
Tulsa, Oklahoma 74135
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