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

Constipation Clinical Trial

Official title:

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 Non-Malignant Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366431
• Other study ID #: 3200A3-200
• Status: Completed
• Phase: Phase 2
• Start date: August 2006
• Est. completion date: March 2007

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Intestinal Diseases

Intervention

Drug:
• MOA-728

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.