CompletedPhase 2

Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain

128 participantsStarted 2008-01

Plain-language summary

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 administered MOA-728 who have chronic pain that is not due to cancer, and who have opioid-induced bowel dysfunction (OIBD).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult Outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer. * Taking oral, transdermal, intravenous, or subcutaneous opioids. * Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives. Exclusion Criteria: * History of chronic constipation before the initiation of opioid therapy. * Other GI disorders known to affect bowel transit. * Women who are pregnant, breast feeding, or plan to become pregnant.

What they're measuring

Percentage of Participants Witn Spontaneous Bowel Movements Within 3 Hours of Treatment

Timeframe: 3 hours

Trial details

NCT IDNCT00605644

SponsorBausch Health Americas, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-05

Results submitted2020-08-08

View on ClinicalTrials.gov More Constipation trials