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Clinical trialNCT01642914CompletedPhase 3Interventional

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

SponsorForest LaboratoriesEnrollment487Chronic ConstipationConstipation
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

151 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • Forest Investigative Site 054

    Greater Sudbury, Ontario, Canada

  • Forest Investigative Site 059

    Sarnia, Ontario, Canada

  • Forest Investigative Site 086

    Toronto, Ontario, Canada

  • Forest Investigative Site 147

    Toronto, Ontario, Canada

  • Forest Investigative Site 152

    Vaughan, Ontario, Canada

United States
  • Forest Investigative Site 020

    Chandler, Arizona, United States

  • Forest Investigative Site 102

    Chandler, Arizona, United States

  • Forest Investigative Site 149

    Glendale, Arizona, United States

  • Forest Investigative Site 126

    Goodyear, Arizona, United States

  • Forest Investigative Site 018

    Phoenix, Arizona, United States

  • Forest Investigative Site 061

    Phoenix, Arizona, United States

  • Forest Investigative Site 022

    Scottsdale, Arizona, United States

  • Forest Investigative Site 071

    Tucson, Arizona, United States

  • Forest Investigative Site 079

    Tucson, Arizona, United States

  • Forest Investigative Site 135

    North Little Rock, Arkansas, United States

  • Forest Investigative Site 106

    Anaheim, California, United States

  • Forest Investigative Site 104

    Laguna Hills, California, United States

  • Forest Investigative Site 066

    Mission Hills, California, United States

  • Forest Investigative Site 095

    San Carlos, California, United States

  • Forest Investigative Site 009

    San Diego, California, United States

  • Forest Investigative Site 151

    Santa Monica, California, United States

  • Forest Investigative Site 010

    Westlake Village, California, United States

  • Forest Investigative Site 012

    Boulder, Colorado, United States

  • Forest Investigative Site 041

    Colorado Springs, Colorado, United States

  • Forest Investigative Site 045

    Colorado Springs, Colorado, United States

  • Forest Investigative Site 060

    Longmont, Colorado, United States

  • Forest Investigative Site 007

    Bristol, Connecticut, United States

  • Forest Investigative Site 153

    Waterbury, Connecticut, United States

  • Forest Investigative Site 091

    Boynton Beach, Florida, United States

  • Forest Investigative Site 047

    Bradenton, Florida, United States

  • Forest Investigative Site 042

    Brooksville, Florida, United States

  • Forest Investigative Site 133

    Coral Gables, Florida, United States

  • Forest Investigative Site 131

    DeLand, Florida, United States

  • Forest Investigative Site 051

    Fort Myers, Florida, United States

  • Forest Investigative Site 137

    Inverness, Florida, United States

  • Forest Investigative Site 114

    Jacksonville, Florida, United States

  • Forest Investigative Site 004

    Jupiter, Florida, United States

  • Forest Investigative Site 016

    Kissimmee, Florida, United States

  • Forest Investigative Site 097

    Lauderdale Lakes, Florida, United States

  • Forest Investigative Site 002

    Miami, Florida, United States

111 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linaclotide 145 microgramsLinaclotide 290 microgramsMatching placebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Aug 2012
Primary completion
31 May 2013
Completion
31 Aug 2013
Last update posted
26 Apr 2016
Registered enrollment
487
Registry id
NCT01642914
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.