CompletedPhase 2

Study Evaluating Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction (OIBD) in Subjects With Chronic Non-Malignant Pain

United States420 participantsStarted 2006-08

Plain-language summary

The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of MOA-728 in subjects with Opioid-Induced Bowel Dysfunction (OIBD) with associated chronic non-malignant pain.

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 non-malignant pain. * Taking oral, transdermal, intravenous, or subcutaneous opioids. * Willingness to discontinue all pre-study laxative therapy and utilize 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

The effect of the interventional treatment will be measured by the change from baseline in the number of bowel movements per week during the double-blind treatment period.

Trial details

NCT IDNCT00366431

SponsorBausch Health Americas, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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