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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00765999

Public ClinicalTrials.gov record NCT00765999. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 8:02 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT00765999
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Forest Laboratories
Industry
Enrollment
1,559 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 31, 2008 (Actual)
Primary completion
Jan 31, 2012 (Actual)
Completion
Jan 31, 2012 (Actual)
Last update posted
Feb 15, 2019

2008 – 2012

United States locations

U.S. sites
110
U.S. states
33
U.S. cities
97
Facility City State ZIP Site status
Innovative Clinical Trials Birmingham Alabama 35205 —
Parkway Medical Center Birmingham Alabama 35215 —
Medical Affiliated Research Center, Inc. Huntsville Alabama 35801 —
Radiant Research, Inc. Chandler Arizona 85224 —
Pivotal Research Centers Peoria Arizona 85381 —
Pivotal Research Center Peoria Arizona 85381 —
Carl T Hayden VA Medical Center GI Section-CS-111G Phoenix Arizona 85012 —
Elite Clinical Studies, LLC Phoenix Arizona 85018 —
Radiant Research, Inc. Scottsdale Arizona 85251 —
Genova Clinical Research, Inc. Tucson Arizona 85704 —
Adobe Clinical Research, LLC Tucson Arizona 85712 —
Providence Clinical Research Burbank California 91505 —
Encompass Clinical Research North Coast Encinitas California 92024 —
Family Medical Center Foothill Ranch California 92610 —
Axis Clinical Trials Los Angeles California 90036 —
Facey Medical Foundation Mission Hills California 91345 —
Advanced Clinical Research Institute Orange California 92869 —
Westlake Medical Research Westlake Village California 91361 —
Boulder Medical Center, P.C. Boulder Colorado 80304 —
Lynn Institute of the Rockies Colorado Springs Colorado 80907 —
Colorado Gastroenterology, Prof LLC Denver Colorado 80205 —
Longmont Medical Research Network Longmont Colorado 80501 —
Western States Clinical Research Wheat Ridge Colorado 80033 —
Chase Medical Research, LLC Waterbury Connecticut 06708 —
Clinical Trials Management of Boca Raton, Inc. Boca Raton Florida 33428 —
Meridien Research Bradenton Florida 34208 —
PAB Clinical Research Brandon Florida 33511 —
Meridien Research Brooksville Florida 34601 —
Clinical Physiology Associates Clinical Study Center Fort Myers Florida 33916 —
Jupiter Research, Inc. Jupiter Florida 33458 —
FPA Clinical Research Kissimmee Florida 34741 —
Pharmax Research Clinic Miami Florida 33126 —
United Medical Research New Smyrna Beach Florida 32168 —
RenStar Medical Research Ocala Florida 34471 —
Compass Research Orlando Florida 32806 —
Emerald Coast Research Associates Panama City Florida 32405 —
University Clinical Research, Inc. Pembroke Pines Florida 33024 —
Miami Research Associates South Miami Florida 33143 —
Meridien Research St. Petersburg Florida 33709 —
Meridien Research Tampa Florida 33606 —
Advanced Research Institute Trinity Florida 34655 —
Florida Medical Clinic, P.A. Clinical Research Division Zephyrhills Florida 33542 —
Radiant Research, Inc. Atlanta Georgia 30342 —
Gastrointestinal Specialists of Georgia, PC Marietta Georgia 30060 —
Atlanta Gastroenterology Associates, LLC Marietta Georgia 30067 —
Clinical Research Atlanta Stockbridge Georgia 30281 —
North Georgia Clinical Research Woodstock Georgia 30189 —
Rosemark WomenCare Specialist Idaho Falls Idaho 83404 —
Rockford Gastroenterology Associates, Ltd. Rockford Illinois 61107 —
MediSphere Medical Research Center, LLC Evansville Indiana 47714 —
University of Iowa Hospitals & Clinics Iowa City Iowa 52242 —
Heartland Research Associates, LLC Arkansas City Kansas 67005 —
Heartland Research Associates, LLC Newton Kansas 67114 —
Heartland Research Associates, LLC Wichita Kansas 67205 —
Heartland Research Associates, LLC Wichita Kansas 67207 —
Central Kentucky Research Associates Lexington Kentucky 40509 —
Trover Health System Madisonville Kentucky 42431 —
Medical Development Centers, LLC Baton Rouge Louisiana 70808 —
Clinical Trials of America, Inc. Shreveport Louisiana 71101 —
Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research Chevy Chase Maryland 20815 —
Meritus Center for Clinical Research Hagerstown Maryland 21742 —
Charm City Research Towson Maryland 21286 —
Boston Clinical Trials Boston Massachusetts 02135 —
Kalamazoo Gastroenterology Hepatology Kalamazoo Michigan 49048 —
Ridgeview Research Two Twelve Medical Center Chaska Minnesota 55318 —
St. Louis Center for Clinical Research St Louis Missouri 63128 —
The Gastroenterology Group of S.J. Vineland New Jersey 08360 —
New Mexico Clinical Research and Osteoporosis Center Albuquerque New Mexico 87106 —
Lifeline Research Institute Brooklyn New York 11214 —
Long Island Clinical Research Associates, LLP Great Neck New York 11021 —
Long Island Gastrointestinal Research Group Great Neck New York 11023 —
Gastrointestinal Research Associates, LLC Setauket New York 11733 —
MediSpect, LLC Boone North Carolina 28607 —
Cumberland Research Associates, LLC Fayetteville North Carolina 28304 —
LeBauer Research Associates, P.A. Greensboro North Carolina 27403 —
Clinical Trials of America, INC Hickory North Carolina 28601 —
Wake Research Associates, LLC Raleigh North Carolina 27612 —
Hanover Medical Specialists, PA Wilmington North Carolina 28401 —
Digestive Health Specialists, PA Winston-Salem North Carolina 27103 —
Consultants for Clinical Research Cincinnati Ohio 45219 —
Rapid Medical Research, Inc. Cleveland Ohio 44122 —
Remington Davis Columbus Ohio 43215 —
Hometown Urgent Care and Research Dayton Ohio 45432 —
Oklahoma Foundation for Digestive Research Oklahoma City Oklahoma 73104 —
Gastroenterology United of Tulsa Tulsa Oklahoma 74135 —
Clinical Trials Research Services, LLC Pittsburgh Pennsylvania 15206 —
Upstate Pharmaceutical Research Greenville South Carolina 29615 —
Mountain View Clinical Research Greer South Carolina 29651 —
Radiant Research Greer South Carolina 29651 —
Nashville Medical Research Institute Nashville Tennessee 37205 —
Professional Quality Research, Inc. Austin Texas 78705 —
Research Across America RHD Professional Plaza IV Dallas Texas 75234 —
Houston Digestive Diseases Clinic Houston Texas 77090 —
Houston Medical Research Associates Houston Texas 77090 —
R/D Clinical Research, Inc. Lake Jackson Texas 77566 —
Quality Research Inc. San Antonio Texas 78209 —
Diagnostics Research Group San Antonio Texas 78229 —
Fatigue Consultation Clinic Salt Lake City Utah 84102 —
Department of Gastroenterology University of Utah Hospital Salt Lake City Utah 84132 —
Department of Veterans Affairs Research Department Salt Lake City Utah 84148 —
Charlottesville Medical Research Charlottesville Virginia 22911 —
New River Valley Research Institute Christiansburg Virginia 24073 —
Health Research of Hampton Roads Newport News Virginia 23606 —
National Clinical Research - Norfolk, Inc. Norfolk Virginia 23502 —
Clinical Research Associates of Tidewater Norfolk Virginia 23507 —
National Clinical Research-Richmond, Inc. Richmond Virginia 23294 —
Northwest Gastroenterology Associates Bellevue Washington 98004 —
Radiant Research, Inc. Lakewood Washington 98499 —
Wenatchee Valley Medical Center Clinical Research Dept. Wenatchee Washington 98801 —
Aurora Advanced Healthcare, Inc. Clinical Research Center Milwaukee Wisconsin 53209 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00765999, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 15, 2019 · Synced Oct 21, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00765999 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →