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

Phase 2

Completed

• Conditions: Constipation

• Registration Number: NCT00366431
• Lead Sponsor: Bausch Health Americas, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-18
• Study First Submitted QC: 2006-08-18
• Study First Posted: 2006-08-21
• Study Completion: 2007-03
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.