Who is sponsoring NCT01367548?

NCT01367548 is sponsored by Bausch Health Americas, Inc..

What drugs are being tested in NCT01367548?

Interventions in NCT01367548: IV Methylnaltrexone (MNTX), Placebo.

What condition does NCT01367548 study?

NCT01367548 studies Postoperative Ileus.

Is NCT01367548 still recruiting?

NCT01367548 is currently completed. Last updated 26 November 2019.

Last reviewed 2019-11-26 · How we verify

NCT01367548

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

A Phase II Double-Blind Randomized Parallel Group Study of Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus

Completed Phase 2 Last updated 26 November 2019

What this trial tests

Phase 2 trial testing IV Methylnaltrexone (MNTX) in Postoperative Ileus in 65 participants. Completed in 1 December 2004.

Timeline

1 July 2003

Primary endpoint
1 December 2004

1 December 2004

Quick facts

Lead sponsor	Bausch Health Americas, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	65
Start date	1 July 2003
Primary completion	1 December 2004
Estimated completion	1 December 2004
Sites	1 location across United States

Drugs / interventions tested

IV Methylnaltrexone (MNTX) — full drug profile →
Placebo

Conditions studied

Postoperative Ileus — all drugs for Postoperative Ileus →

Sponsor

Bausch Health Americas, Inc. — full company profile →

Who can join

18 and older, any sex, with Postoperative Ileus. 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.

Time to tolerance of liquids
Time frame: 7 days
To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.

Sponsor's own description

A double-blind, randomized, parallel-group study designed to evaluate the safety and activity of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent segmental colectomies via laparotomy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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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 NCT01367548 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bausch Health Americas, Inc.
Last refreshed: 26 November 2019

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/NCT01367548.

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