Study Evaluating Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction (OIBD) in Subjects With Chronic Non-Malignant Pain
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
1 other identifier
interventional
420
1 country
67
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2006
Shorter than P25 for phase_2
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 18, 2006
CompletedFirst Posted
Study publicly available on registry
August 21, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedNovember 25, 2019
November 1, 2019
August 18, 2006
November 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Unknown Facility
Birmingham, Alabama, 35215, United States
Unknown Facility
Birmingham, Alabama, 35244, United States
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Phoenix, Arizona, 85029, United States
Unknown Facility
Tucson, Arizona, 85710, United States
Unknown Facility
Tucson, Arizona, 85712, United States
Unknown Facility
Tucson, Arizona, 85741, United States
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Hot Springs, Arkansas, 71913, United States
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Anaheim, California, 92805, United States
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Bakersfield, California, 93311, United States
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Foothill Ranch, California, 92610, United States
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Garden Grove, California, 92843, United States
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Los Gatos, California, 95032, United States
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Orange, California, 92869, United States
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Sacramento, California, 95831, United States
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San Diego, California, 92108, United States
Unknown Facility
San Diego, California, 92120, United States
Unknown Facility
San Diego, California, 92121, United States
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Trumbull, Connecticut, 06611, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32216, United States
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Jupiter, Florida, 33458, United States
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Largo, Florida, 33770, United States
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Miami, Florida, 33173, United States
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Miami, Florida, 33180, United States
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Ocala, Florida, 34471, United States
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Ormond Beach, Florida, 32174, United States
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Saint Cloud, Florida, 34769, United States
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Tampa, Florida, 33607, United States
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West Palm Beach, Florida, 33401, United States
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Dawsonville, Georgia, 30534, United States
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Marietta, Georgia, 30060, United States
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Marietta, Georgia, 30066, United States
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Bloomington, Illinois, 61701, United States
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Chicago, Illinois, 60610, United States
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Indianapolis, Indiana, 46250, United States
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Elkridge, Maryland, 21075, United States
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Boston, Massachusetts, 02115, United States
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Brockton, Massachusetts, 02301, United States
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Saginaw, Michigan, 48602, United States
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Traverse City, Michigan, 49684, United States
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Picayune, Mississippi, 39466, United States
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Independence, Missouri, 64055, United States
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Missoula, Montana, 59808, United States
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Omaha, Nebraska, 68114, United States
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Reno, Nevada, 89502, United States
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Haddon Heights, New Jersey, 08035, United States
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Albuquerque, New Mexico, 87102, United States
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Great Neck, New York, 11023, United States
Unknown Facility
Lake Success, New York, 11042, United States
Unknown Facility
Charlotte, North Carolina, 28210, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Cincinnati, Ohio, 45224, United States
Unknown Facility
Dayton, Ohio, 45439, United States
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Clinton, Oklahoma, 73601, United States
Unknown Facility
Chattanooga, Tennessee, 37404, United States
Unknown Facility
Beaumont, Texas, 77701, United States
Unknown Facility
Colleyville, Texas, 76034, United States
Unknown Facility
San Antonio, Texas, 78205, United States
Unknown Facility
San Antonio, Texas, 78209, United States
Unknown Facility
San Antonio, Texas, 78238, United States
Unknown Facility
Alexandria, Virginia, 22304, United States
Unknown Facility
Christiansburg, Virginia, 24073, United States
Unknown Facility
Norfolk, Virginia, 23502, United States
Unknown Facility
Richmond, Virginia, 23229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jeff Cohn
Bausch Health Americas, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 18, 2006
First Posted
August 21, 2006
Study Start
August 1, 2006
Study Completion
March 1, 2007
Last Updated
November 25, 2019
Record last verified: 2019-11