Who is sponsoring NCT00460811?

NCT00460811 is sponsored by Ironwood Pharmaceuticals, Inc..

What drugs are being tested in NCT00460811?

Interventions in NCT00460811: Linaclotide Acetate, Matching placebo.

What condition does NCT00460811 study?

NCT00460811 studies Irritable Bowel Syndrome With Constipation.

Is NCT00460811 still recruiting?

NCT00460811 is currently completed. Last updated 29 January 2013.

Are results published for NCT00460811?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2013-01-29 · How we verify

NCT00460811

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Multicenter, Double-blind, Placebo-controlled, Dose-range-finding, Parallel-design, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Irritable Bowel Syndrome With Constipation

Completed Phase 2 Results posted Last updated 29 January 2013

What this trial tests

Phase 2 trial testing Linaclotide Acetate in Irritable Bowel Syndrome With Constipation in 420 participants. Completed in 1 April 2008.

Timeline

1 April 2007

Primary endpoint
1 February 2008

1 April 2008

Quick facts

Lead sponsor	Ironwood Pharmaceuticals, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	420
Start date	1 April 2007
Primary completion	1 February 2008
Estimated completion	1 April 2008
Sites	85 locations across United States, Canada

Drugs / interventions tested

Linaclotide Acetate — full drug profile →
Matching placebo — full drug profile →

Conditions studied

Irritable Bowel Syndrome With Constipation — all drugs for Irritable Bowel Syndrome With Constipation →

Sponsor

Ironwood Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Irritable Bowel Syndrome With Constipation. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period
Time frame: Change from Baseline to Week 12
The change in the weekly normalized CSBM Rate during Weeks 1 through 12 of the Treatment Period from the weekly normalized CSBM Rate obtained during the Pretreatment Period. The CSBM rate was normalized based on the number of CSBMs occurring in that week, adjusting for differences in the duration of the week and black-out periods (time not covered due to a missed IVRS call) versus 7x24 hours.

Sponsor's own description

The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Review article: Linaclotide for the management of irritable bowel syndrome with constipation.
Layer P, Stanghellini V. · · 2014 · cited 54× · PMID 24433216 · DOI 10.1111/apt.12604
Luminally Acting Agents for Constipation Treatment: A Review Based on Literatures and Patents.
Yang H, Ma T. · · 2017 · cited 6× · PMID 28713271 · DOI 10.3389/fphar.2017.00418
Linaclotide: a new option for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation in adults.
Parker CH, Yuan Y, Liu LW. · · 2013 · cited 5× · PMID 24833940 · DOI 10.4137/cgast.s10550

Verify or expand the search:

Other recruiting trials for Irritable Bowel Syndrome With Constipation

Currently open trials in the same condition.

NCT06219707 — Electro-acupuncture for Irritable Bowel Syndrome With Constipation · NA · recruiting

Other Ironwood Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT05740007 — A Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrom · Phase 2 · terminated
NCT05362695 — A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects · Phase 1 · completed
NCT05188261 — A Study of Single Ascending Doses of IW-3300 in Healthy Volunteers · Phase 1 · completed
NCT03931785 — A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome · Phase 2 · completed
NCT03856970 — Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Dig · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00460811 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ironwood Pharmaceuticals, Inc.
Last refreshed: 29 January 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00460811.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing