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

NCT ID: NCT00366431

Last Updated: 2019-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-03-31

Brief Summary

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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

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Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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MOA-728

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Salix Pharmaceuticals

Principal Investigators

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Jeff Cohn

Role: STUDY_DIRECTOR

Bausch Health Americas, Inc.

Locations

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Hot Springs, Arkansas, United States

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Anaheim, California, United States

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Anaheim, California, United States

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Bakersfield, California, United States

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Foothill Ranch, California, United States

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Garden Grove, California, United States

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Los Gatos, California, United States

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Orange, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Trumbull, Connecticut, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Jupiter, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Ormond Beach, Florida, United States

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Saint Cloud, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Dawsonville, Georgia, United States

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Marietta, Georgia, United States

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Marietta, Georgia, United States

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Bloomington, Illinois, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Elkridge, Maryland, United States

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Boston, Massachusetts, United States

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Brockton, Massachusetts, United States

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Saginaw, Michigan, United States

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Traverse City, Michigan, United States

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Picayune, Mississippi, United States

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Independence, Missouri, United States

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Missoula, Montana, United States

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Omaha, Nebraska, United States

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Reno, Nevada, United States

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Haddon Heights, New Jersey, United States

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Albuquerque, New Mexico, United States

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Great Neck, New York, United States

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Lake Success, New York, United States

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Charlotte, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Clinton, Oklahoma, United States

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Chattanooga, Tennessee, United States

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Beaumont, Texas, United States

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Colleyville, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Alexandria, Virginia, United States

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Christiansburg, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Countries

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United States

Other Identifiers

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3200A3-200

Identifier Type: -

Identifier Source: org_study_id

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