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

November 21, 2019 updated by: Bausch Health Americas, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

420

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
      • Birmingham, Alabama, United States, 35244
      • Mobile, Alabama, United States, 36608
    • Arizona
      • Phoenix, Arizona, United States, 85029
      • Tucson, Arizona, United States, 85712
      • Tucson, Arizona, United States, 85741
      • Tucson, Arizona, United States, 85710
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
    • California
      • Anaheim, California, United States, 92805
      • Anaheim, California, United States, 92801
      • Bakersfield, California, United States, 93311
      • Foothill Ranch, California, United States, 92610
      • Garden Grove, California, United States, 92843
      • Los Gatos, California, United States, 95032
      • Orange, California, United States, 92869
      • Sacramento, California, United States, 95831
      • San Diego, California, United States, 92108
      • San Diego, California, United States, 92120
      • San Diego, California, United States, 92121
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
    • Florida
      • Hollywood, Florida, United States, 33021
      • Jacksonville, Florida, United States, 32216
      • Jupiter, Florida, United States, 33458
      • Largo, Florida, United States, 33770
      • Miami, Florida, United States, 33173
      • Miami, Florida, United States, 33180
      • Ocala, Florida, United States, 34471
      • Ormond Beach, Florida, United States, 32174
      • Saint Cloud, Florida, United States, 34769
      • Tampa, Florida, United States, 33607
      • West Palm Beach, Florida, United States, 33401
    • Georgia
      • Dawsonville, Georgia, United States, 30534
      • Marietta, Georgia, United States, 30060
      • Marietta, Georgia, United States, 30066
    • Illinois
      • Bloomington, Illinois, United States, 61701
      • Chicago, Illinois, United States, 60610
    • Indiana
      • Indianapolis, Indiana, United States, 46250
    • Maryland
      • Elkridge, Maryland, United States, 21075
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
      • Brockton, Massachusetts, United States, 02301
    • Michigan
      • Saginaw, Michigan, United States, 48602
      • Traverse City, Michigan, United States, 49684
    • Mississippi
      • Picayune, Mississippi, United States, 39466
    • Missouri
      • Independence, Missouri, United States, 64055
    • Montana
      • Missoula, Montana, United States, 59808
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • Nevada
      • Reno, Nevada, United States, 89502
    • New Jersey
      • Haddon Heights, New Jersey, United States, 08035
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
    • New York
      • Great Neck, New York, United States, 11023
      • Lake Success, New York, United States, 11042
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cincinnati, Ohio, United States, 45224
      • Dayton, Ohio, United States, 45439
    • Oklahoma
      • Clinton, Oklahoma, United States, 73601
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
    • Texas
      • Beaumont, Texas, United States, 77701
      • Colleyville, Texas, United States, 76034
      • San Antonio, Texas, United States, 78209
      • San Antonio, Texas, United States, 78238
      • San Antonio, Texas, United States, 78205
    • Virginia
      • Alexandria, Virginia, United States, 22304
      • Christiansburg, Virginia, United States, 24073
      • Norfolk, Virginia, United States, 23502
      • Richmond, Virginia, United States, 23229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Investigators

  • Study Director: Jeff Cohn, Bausch Health Americas, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

August 18, 2006

First Submitted That Met QC Criteria

August 18, 2006

First Posted (Estimate)

August 21, 2006

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3200A3-200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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