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

Bausch Health Americas, Inc.128 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

128

Conditions

Constipation

Interventions

MOA-728DRUG

Oral Capsules

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 3 hours

Data from ClinicalTrials.gov

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