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Completed Phase 3 Interventional Accepts healthy volunteers Results available

Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating

ClinicalTrials.gov ID: NCT01642914

Public ClinicalTrials.gov record NCT01642914. 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 27, 2026, 7:24 PM EDT

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

Official title

Phase 3b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Chronic Constipation and Prominent Abdominal Bloating at Baseline

Brief summary

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

The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients who are eligible will be randomized to one of two doses of linaclotide or placebo for 12 weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency, as well as other abdominal and bowel symptoms of CC.

Study identification

NCT ID
NCT01642914
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Forest Laboratories
Industry
Enrollment
487 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

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

Study timeline

Start date
Aug 2012 (Type not available)
Primary completion
May 2013 (Actual)
Completion
Aug 2013 (Actual)
Last update posted
Apr 26, 2016

2012 – 2013

United States locations

U.S. sites
146
U.S. states
35
U.S. cities
128
Facility City State ZIP Site status
Forest Investigative Site 020 Chandler Arizona 85224 —
Forest Investigative Site 102 Chandler Arizona 85224 —
Forest Investigative Site 149 Glendale Arizona 85308 —
Forest Investigative Site 126 Goodyear Arizona 85395 —
Forest Investigative Site 018 Phoenix Arizona 85018 —
Forest Investigative Site 061 Phoenix Arizona 85020 —
Forest Investigative Site 022 Scottsdale Arizona 85251 —
Forest Investigative Site 079 Tucson Arizona 85704 —
Forest Investigative Site 071 Tucson Arizona 85712 —
Forest Investigative Site 135 North Little Rock Arkansas 72117 —
Forest Investigative Site 106 Anaheim California 92801 —
Forest Investigative Site 104 Laguna Hills California 92653 —
Forest Investigative Site 066 Mission Hills California 91345 —
Forest Investigative Site 095 San Carlos California 94070 —
Forest Investigative Site 009 San Diego California 92108 —
Forest Investigative Site 151 Santa Monica California 90404 —
Forest Investigative Site 010 Westlake Village California 91361 —
Forest Investigative Site 012 Boulder Colorado 80304 —
Forest Investigative Site 041 Colorado Springs Colorado 80904 —
Forest Investigative Site 045 Colorado Springs Colorado 80907 —
Forest Investigative Site 060 Longmont Colorado 80501 —
Forest Investigative Site 007 Bristol Connecticut 06010 —
Forest Investigative Site 153 Waterbury Connecticut 06708 —
Forest Investigative Site 091 Boynton Beach Florida 33426 —
Forest Investigative Site 047 Bradenton Florida 34208 —
Forest Investigative Site 042 Brooksville Florida 34601 —
Forest Investigative Site 133 Coral Gables Florida 33134 —
Forest Investigative Site 131 DeLand Florida 32720 —
Forest Investigative Site 051 Fort Myers Florida 33916 —
Forest Investigative Site 137 Inverness Florida 34452 —
Forest Investigative Site 114 Jacksonville Florida 32205 —
Forest Investigative Site 004 Jupiter Florida 33458 —
Forest Investigative Site 016 Kissimmee Florida 34741 —
Forest Investigative Site 097 Lauderdale Lakes Florida 33319 —
Forest Investigative Site 003 Miami Florida 33143 —
Forest Investigative Site 002 Miami Florida 33183 —
Forest Investigative Site 130 New Smyrna Beach Florida 32168 —
Forest Investigative Site 040 Ocala Florida 34471 —
Forest Investigative Site 083 Orlando Florida 32806 —
Forest Investigative Site 150 Oviedo Florida 32765 —
Forest Investigative Site 132 Port Orange Florida 32129 —
Forest Investigative Site 127 Seminole Florida 33777 —
Forest Investigative Site 087 St. Petersburg Florida 33709 —
Forest Investigative Site 064 Tampa Florida 33606 —
Forest Investigative Site 115 Zephyrhills Florida 33542 —
Forest Investigative Site 021 Marietta Georgia 30060 —
Forest Investigative Site 011 Marietta Georgia 30067 —
Forest Investigative Site 109 Sandy Springs Georgia 30328 —
Forest Investigative Site 037 Stockbridge Georgia 30281 —
Forest Investigative Site 023 Woodstock Georgia 30189 —
Forest Investigative Site 015 Idaho Falls Idaho 83404 —
Forest Investigative Site 122 Peoria Illinois 61602 —
Forest Investigative Site 043 Rockford Illinois 61107 —
Forest Investigative Site 107 Anderson Indiana 46011 —
Forest Investigative Site 117 Clive Iowa 50325 —
Forest Investigative Site 146 Clive Iowa 50325 —
Forest Investigative Site 143 Davenport Iowa 52807 —
Forest Investigative Site 055 Iowa City Iowa 52242 —
Forest Investigative Site 028 Newton Kansas 67114 —
Forest Investigative Site 112 Overland Park Kansas 66215 —
Forest Investigative Site 034 Wichita Kansas 67205 —
Forest Investigative Site 032 Wichita Kansas 67207 —
Forest Investigative Site 128 Lexington Kentucky 40509 —
Forest Investigative Site 134 Madisonville Kentucky 42431 —
Forest Investigative Site 121 Baton Rouge Louisiana 70809 —
Forest Investigative Site 124 Metairie Louisiana 70006 —
Forest Investigative Site 101 Monroe Louisiana 71201 —
Forest Investigative Site 058 Shreveport Louisiana 71101 —
Forest Investigative Site 099 Shreveport Louisiana 71103 —
Forest Investigative Site 062 Baltimore Maryland 21215 —
Forest Investigative Site 008 Chevy Chase Maryland 20815 —
Forest Investigative Site 014 Hagerstown Maryland 21742 —
Forest Investigative Site 024 Towson Maryland 21286 —
Forest Investigative Site 006 Boston Massachusetts 02135 —
Forest Investigative Site 070 Chesterfield Michigan 48047 —
Forest Investigative Site 145 Traverse City Michigan 49684 —
Forest Investigative Site 141 Jackson Mississippi 39202 —
Forest Investigative Site 077 Fremont Nebraska 68025 —
Forest Investigative Site 048 Omaha Nebraska 68134 —
Forest Investigative Site 052 Henderson Nevada 89014 —
Forest Investigative Site 080 Las Vegas Nevada 89121 —
Forest Investigative Site 036 Clifton New Jersey 07012 —
Forest Investigative Site 088 Marlton New Jersey 08053 —
Forest Investigative Site 033 Vineland New Jersey 08360 —
Forest Investigative Site 063 Albuquerque New Mexico 87106 —
Forest Investigative Site 093 Albuquerque New Mexico 87108 —
Forest Investigative Site 044 Brooklyn New York 11206 —
Forest Investigative Site 017 Great Neck New York 11021 —
Forest Investigative Site 142 Asheboro North Carolina 27203 —
Forest Investigative Site 094 Asheville North Carolina 28801 —
Forest Investigative Site 075 Boone North Carolina 28607 —
Forest Investigative Site 123 Chapel Hill North Carolina 27599-7080 —
Forest Investigative Site 140 Davidson North Carolina 28036 —
Forest Investigative Site 039 Fayetteville North Carolina 28304 —
Forest Investigative Site 031 Greensboro North Carolina 27403 —
Forest Investigative Site 029 Greensboro North Carolina 27408 —
Forest Investigative Site 078 Greensboro North Carolina 27408 —
Forest Investigative Site 084 Harrisburg North Carolina 28075 —
Forest Investigative Site 073 Hickory North Carolina 28601 —
Forest Investigative Site 050 Hickory North Carolina 28602 —
Forest Investigative Site 139 High Point North Carolina 27262 —
Forest Investigative Site 027 Raleigh North Carolina 27612 —
Forest Investigative Site 119 Statesville North Carolina 28625 —
Forest Investigative Site 089 Wilmington North Carolina 28401 —
Forest Investigative Site 074 Winston-Salem North Carolina 27103 —
Forest Investigative Site 025 Cincinnati Ohio 45242 —
Forest Investigative Site 120 Cincinnati Ohio 45249 —
Forest Investigative Site 056 Cleveland Ohio 44122 —
Forest Investigative Site 026 Columbus Ohio 43215 —
Forest Investigative Site 098 Dayton Ohio 45415 —
Forest Investigative Site 090 Dayton Ohio 45432 —
Forest Investigative Site 085 Mentor Ohio 44060 —
Forest Investigative Site 068 Wadsworth Ohio 44281 —
Forest Investigative Site 118 Oklahoma City Oklahoma 73104 —
Forest Investigative Site 081 Levittown Pennsylvania 19056 —
Forest Investigative Site 001 Pittsburgh Pennsylvania 15206 —
Forest Investigative Site 110 Reading Pennsylvania 19606 —
Forest Investigative Site 116 Greer South Carolina 29650 —
Forest Investigative Site 046 Simpsonville South Carolina 29681 —
Forest Investigative Site 092 Dakota Dunes South Dakota 57049 —
Forest Investigative Site 129 Chattanooga Tennessee 37421 —
Forest Investigative Site 138 Kingsport Tennessee 37660 —
Forest Investigative Site 125 Austin Texas 78756 —
Forest Investigative Site 035 Dallas Texas 75231 —
Forest Investigative Site 005 Dallas Texas 75234 —
Forest Investigative Site 111 Fort Worth Texas 76135 —
Forest Investigative Site 100 Houston Texas 77034 —
Forest Investigative Site 067 Katy Texas 77450 —
Forest Investigative Site 049 Pasadena Texas 77505 —
Forest Investigative Site 030 San Antonio Texas 78209 —
Forest Investigative Site 076 San Antonio Texas 78229 —
Forest Investigative Site 065 Sugarland Texas 77479 —
Forest Investigative Site 019 Ogden Utah 84405 —
Forest Investigative Site 105 Salt Lake City Utah 84107 —
Forest Investigative Site 113 Sandy City Utah 84094 —
Forest Investigative Site 053 Charlottesville Virginia 22911 —
Forest Investigative Site 108 Chesapeake Virginia 23320 —
Forest Investigative Site 136 Chesapeake Virginia 23320 —
Forest Investigative Site 148 Christiansburg Virginia 24073 —
Forest Investigative Site 072 Lynchburg Virginia 24502 —
Forest Investigative Site 069 Newport News Virginia 23606 —
Forest Investigative Site 013 Norfolk Virginia 23502 —
Forest Investigative Site 038 Richmond Virginia 23294 —
Forest Investigative Site 103 Spokane Washington 99208 —
Forest Investigative Site 082 La Crosse Wisconsin 54601 —
Forest Investigative Site 096 Milwaukee Wisconsin 53215 —

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 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01642914, 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 Apr 26, 2016 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01642914 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →