NCT00402337 is a Phase 2 clinical trial of linaclotide acetate in Chronic Constipation, sponsored by Ironwood Pharmaceuticals, Inc..

Who is sponsoring NCT00402337?

NCT00402337 is sponsored by Ironwood Pharmaceuticals, Inc..

What drugs are being tested in NCT00402337?

Interventions in NCT00402337: linaclotide acetate, Matching placebo.

What condition does NCT00402337 study?

NCT00402337 studies Chronic Constipation.

Is NCT00402337 still recruiting?

NCT00402337 is currently completed. Last updated 29 January 2013.

Are results published for NCT00402337?

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

NCT00402337

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-group, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation

Completed Phase 2 Results posted Last updated 29 January 2013

What this trial tests

Phase 2 trial testing linaclotide acetate in Chronic Constipation in 310 participants. Completed in 1 February 2008.

Timeline

1 November 2006

Primary endpoint
1 December 2007

1 February 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	310
Start date	1 November 2006
Primary completion	1 December 2007
Estimated completion	1 February 2008
Sites	60 locations across United States

Drugs / interventions tested

linaclotide acetate — full drug profile →
Matching placebo — full drug profile →

Conditions studied

Chronic Constipation — all drugs for Chronic Constipation →

Sponsor

Ironwood Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Chronic 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 Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency
Time frame: Change from Baseline to Week 4
Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period.

Sponsor's own description

The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

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

Verify or expand the search:

Other recruiting trials for Chronic Constipation

Currently open trials in the same condition.

NCT07387952 — The Safety and Efficacy of Fecal Microbiota Transplantation Combined With Nutritional Intervention in the Treatment of F · NA · recruiting
NCT06911749 — MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders · NA · recruiting
NCT06847919 — Exploring the Potential Benefits of Probiotic Yogurt · NA · recruiting
NCT06543979 — Anorectal Manometery in Pediatric Chronic Refractory Constipation · Phase 1, PHASE2 · recruiting
NCT03819062 — Sacral Neuromodulation as Treatment for Chronic 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 NCT00402337 (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/NCT00402337.

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