Who is sponsoring NCT00547586?

NCT00547586 is sponsored by Bausch Health Americas, Inc..

What condition does NCT00547586 study?

NCT00547586 studies Constipation.

What drugs are being tested in NCT00547586?

Interventions: N-methylnaltrexone bromide (MOA-728), placebo.

What is the status of NCT00547586?

NCT00547586 is currently COMPLETED.

Last reviewed 2020-08-08 · How we verify

A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study of Oral MOA-728 for the Treatment of Opioid- Induced Bowel Dysfunction in Subjects With Chronic Nonmalignant Pain

NCT00547586 Phase 2 COMPLETED Results posted

The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel dysfunction (OIBD).

Details

Lead sponsor	Bausch Health Americas, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	122
Start date	2007-10
Completion	2008-02

Conditions

Constipation

Interventions

N-methylnaltrexone bromide (MOA-728)
placebo

Primary outcomes

Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment — 6 hours

Countries

United States