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

Last updated: November 21, 2019
Sponsor: Bausch Health Americas, Inc.
Overall Status: Completed

Phase

2

Condition

Constipation

Gastrointestinal Diseases And Disorders

Treatment

N/A

Clinical Study ID

NCT00366431
3200A3-200
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult outpatients with opioid-induced bowel dysfunction and chronic non-malignantpain.

  • Taking oral, transdermal, intravenous, or subcutaneous opioids.

  • Willingness to discontinue all pre-study laxative therapy and utilize only studypermitted rescue laxatives.

Exclusion

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

Total Participants: 420
Study Start date:
August 01, 2006
Estimated Completion Date:
March 31, 2007

Connect with a study center

  • Birmingham, Alabama 35244
    United States

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  • Mobile, Alabama 36608
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  • Phoenix, Arizona 85029
    United States

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  • Tucson, Arizona 85710
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  • Hot Springs, Arkansas 71913
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  • Anaheim, California 92801
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  • Bakersfield, California 93311
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  • Foothill Ranch, California 92610
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  • Garden Grove, California 92843
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  • Los Gatos, California 95032
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  • Orange, California 92869
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  • Sacramento, California 95831
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  • San Diego, California 92120
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  • Trumbull, Connecticut 06611
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  • Hollywood, Florida 33021
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  • Jacksonville, Florida 32216
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  • Jupiter, Florida 33458
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  • Largo, Florida 33770
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  • Miami, Florida 33180
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  • Ocala, Florida 34471
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  • Ormond Beach, Florida 32174
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  • Saint Cloud, Florida 34769
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    St. Cloud, Florida 34769
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  • Tampa, Florida 33607
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  • West Palm Beach, Florida 33401
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  • Dawsonville, Georgia 30534
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  • Marietta, Georgia 30060
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  • Bloomington, Illinois 61701
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  • Chicago, Illinois 60610
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  • Indianapolis, Indiana 46250
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  • Elkridge, Maryland 21075
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  • Boston, Massachusetts 02115
    United States

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  • Brockton, Massachusetts 02301
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  • Saginaw, Michigan 48602
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  • Traverse City, Michigan 49684
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  • Picayune, Mississippi 39466
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  • Independence, Missouri 64055
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  • Missoula, Montana 59808
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  • Omaha, Nebraska 68114
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  • Reno, Nevada 89502
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  • Haddon Heights, New Jersey 08035
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  • Albuquerque, New Mexico 87102
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  • Great Neck, New York 11023
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  • Lake Success, New York 11042
    United States

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  • Charlotte, North Carolina 28210
    United States

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  • Winston-Salem, North Carolina 27103
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  • Cincinnati, Ohio 45224
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  • Dayton, Ohio 45439
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  • Clinton, Oklahoma 73601
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  • Chattanooga, Tennessee 37404
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  • Beaumont, Texas 77701
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  • Colleyville, Texas 76034
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  • San Antonio, Texas 78238
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  • Alexandria, Virginia 22304
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  • Christiansburg, Virginia 24073
    United States

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  • Norfolk, Virginia 23502
    United States

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  • Richmond, Virginia 23229
    United States

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