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Completed Phase 3 Interventional Results available

Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation

ClinicalTrials.gov ID: NCT00948818

Public ClinicalTrials.gov record NCT00948818. 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 Sep 4, 2026, 4:38 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

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients With Irritable Bowel Syndrome With Constipation

Brief summary

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

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.

Study identification

NCT ID
NCT00948818
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Forest Laboratories
Industry
Enrollment
803 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
Jun 30, 2009
Primary completion
Jun 30, 2010
Completion
Jul 31, 2010
Last update posted
Jan 29, 2013

2009 – 2010

United States locations

U.S. sites
111
U.S. states
33
U.S. cities
97
Facility City State ZIP Site status
Forest Investigative Site 037 Birmingham Alabama 35209
Forest Investigative Site 036 Birmingham Alabama 35215
Forest Investigative Site 135 Hueytown Alabama 35023
Forest Investigative Site 014 Huntsville Alabama 35801
Forest Investigative Site 080 Chandler Arizona 85225
Forest Investigative Site 053 Mesa Arizona 85210
Forest Investigative Site 078 Peoria Arizona 85381
Forest Investigative Site 101 Phoenix Arizona 85012
Forest Investigative Site 128 Phoenix Arizona 85018
Forest Investigative Site 051 Scottsdale Arizona 85251
Forest Investigative Site 136 Tucson Arizona 85712
Forest Investigative Site 087 Tucson Arizona 85741
Forest Investigative Site 094 Burbank California 91505
Forest Investigative Site 026 Encinitas California 92024
Forest Investigative Site 096 Foothill Ranch California 92610
Forest Investigative Site 057 Los Angeles California 90036
Forest Investigative Site 097 Mission Hills California 91345
Forest Investigative Site 005 Orange California 92869
Forest Investigative Site 024 Westlake Village California 91361
Forest Investigative Site 021 Boulder Colorado 80304
Forest Investigative Site 019 Colorado Springs Colorado 80907
Forest Investigative Site 034 Denver Colorado 80205
Forest Investigative Site 074 Longmont Colorado 80501
Forest Investigative Site 010 Wheat Ridge Colorado 80033
Forest Investigative Site 058 Waterbury Connecticut 06708
Forest Investigative Site 042 Boca Raton Florida 33486
Forest Investigative Site 003 Bradenton Florida 34203
Forest Investigative Site 137 Brandon Florida 33511
Forest Investigative Site 070 Brooksville Florida 34613
Forest Investigative Site 018 Fort Myers Florida 33916
Forest Investigative Site 030 Jupiter Florida 33458
Forest Investigative Site 077 Kissimmee Florida 34741
Forest Investigative Site 133 Miami Florida 33126
Forest Investigative Site 031 Miami Florida 33143
Forest Investigative Site 129 New Smyrna Beach Florida 32168
Forest Investigative Site 108 Ocala Florida 34471
Forest Investigative Site 092 Orlando Florida 32806
Forest Investigative Site 038 Panama City Florida 32405
Forest Investigative Site 027 Pembroke Pines Florida 33024
Forest Investigative Site 045 St. Petersburg Florida 33709
Forest Investigative Site 015 Tampa Florida 33606
Forest Investigative Site 104 Trinity Florida 34655
Forest Investigative Site 068 Zephyrhills Florida 33542
Forest Investigative Site 032 Atlanta Georgia 30342
Forest Investigative Site 103 Atlanta Georgia 30342
Forest Investigative Site 033 Marietta Georgia 30060
Forest Investigative Site 020 Marietta Georgia 30067
Forest Investigative Site 040 Woodstock Georgia 30189
Forest Investigative Site 055 Idaho Falls Idaho 83404
Forest Investigative Site 043 Rockford Illinois 61107
Forest Investigative Site 047 Evansville Indiana 47714
Forest Investigative Site 046 Iowa City Iowa 52242
Forest Investigative Site 029 Arkansas City Kansas 67005
Forest Investigative Site 009 Newton Kansas 67114
Forest Investigative Site 023 Wichita Kansas 67205
Forest Investigative Site 093 Wichita Kansas 67207
Forest Investigative Site 067 Lexington Kentucky 40509
Forest Investigative Site 114 Madisonville Kentucky 42431
Forest Investigative Site 132 Baton Rouge Louisiana 70808
Forest Investigative Site 124 Shreveport Louisiana 71101
Forest Investigative Site 013 Chevy Chase Maryland 20815
Forest Investigative Site 006 Hagerstown Maryland 21742
Forest Investigative Site 073 Lutherville Maryland 21093
Forest Investigative Site 001 Boston Massachusetts 02135
Forest Investigative Site 125 Kalamazoo Michigan 49048
Forest Investigative Site 064 Chaska Minnesota 55318
Forest Investigative Site 004 St Louis Missouri 63128
Forest Investigative Site 085 Vineland New Jersey 08360
Forest Investigative Site 052 Albuquerque New Mexico 87106
Forest Investigative Site 035 Brooklyn New York 11214
Forest Investigative Site 017 Great Neck New York 11021
Forest Investigative Site 011 Great Neck New York 11023
Forest Investigative Site 134 Setauket New York 11733
Forest Investigative Site 122 Boone North Carolina 28607
Forest Investigative Site 072 Fayetteville North Carolina 28304
Forest Investigative Site 016 Greensboro North Carolina 27403
Forest Investigative Site 119 Hickory North Carolina 28601
Forest Investigative Site 088 Raleigh North Carolina 27612
Forest Investigative Site 056 Wilmington North Carolina 28401
Forest Investigative Site 065 Winston-Salem North Carolina 27103
Forest Investigative Site 028 Cincinnati Ohio 45219
Forest Investigative Site 044 Cleveland Ohio 44122
Forest Investigative Site 123 Columbus Ohio 43215
Forest Investigative Site 130 Dayton Ohio 45432
Forest Investigative Site 082 Oklahoma City Oklahoma 73104
Forest Investigative Site 102 Tulsa Oklahoma 74135
Forest Investigative Site 039 Pittsburgh Pennsylvania 15206
Forest Investigative Site 121 Greenville South Carolina 29615
Forest Investigative Site 069 Greer South Carolina 29651
Forest Investigative Site 131 Greer South Carolina 29651
Forest Investigative Site 025 Nashville Tennessee 37205
Forest Investigative Site 099 Austin Texas 78705
Forest Investigative Site 002 Dallas Texas 75234
Forest Investigative Site 041 Houston Texas 77090
Forest Investigative Site 110 Houston Texas 77090
Forest Investigative Site 063 Lake Jackson Texas 77566
Forest Investigative Site 095 San Antonio Texas 78209
Forest Investigative Site 076 San Antonio Texas 78229
Forest Investigative Site 089 Salt Lake City Utah 84102
Forest Investigative Site 091 Salt Lake City Utah 84132
Forest Investigative Site 100 Salt Lake City Utah 84148
Forest Investigative Site 054 Charlottesville Virginia 22911
Forest Investigative Site 061 Christianburg Virginia 24073
Forest Investigative Site 007 Newport News Virginia 23606
Forest Investigative Site 060 Norfolk Virginia 23502
Forest Investigative Site 075 Norfolk Virginia 23507
Forest Investigative Site 050 Richmond Virginia 23294
Forest Investigative Site 049 Bellevue Washington 98402
Forest Investigative Site 098 Lakewood Washington 98499
Forest Investigative Site 066 Wenatchee Washington 98801
Forest Investigative Site 083 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 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00948818, 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 Jan 29, 2013 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00948818 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →