Study Evaluating Oral MOA-728 For The Treatment Of 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 Nonmalignant Pain
1 other identifier
interventional
122
1 country
41
Brief Summary
The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel dysfunction (OIBD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2007
Shorter than P25 for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 19, 2007
CompletedFirst Posted
Study publicly available on registry
October 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
August 20, 2020
CompletedAugust 20, 2020
August 1, 2020
4 months
October 19, 2007
August 8, 2020
August 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment
6 hours
Study Arms (5)
Placebo
PLACEBO COMPARATOR150 mg
EXPERIMENTAL300 mg
EXPERIMENTAL450 mg
EXPERIMENTAL600 mg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Adult outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
- Taking oral, transdermal, intravenous, or subcutaneous opioids.
- Willingness to discontinue all pre-study laxative therapy and use 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
- Bausch Health Americas, Inc.lead
- Progenics Pharmaceuticals, Inc.collaborator
Study Sites (41)
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Litchfield Park, Arizona, 85340, United States
Unknown Facility
Tucson, Arizona, 85710, United States
Unknown Facility
Tucson, Arizona, 85741, United States
Unknown Facility
Hot Springs, Arkansas, 71901, United States
Unknown Facility
Hot Springs, Arkansas, 71903, United States
Unknown Facility
Garden Grove, California, 92843, United States
Unknown Facility
Long Beach, California, 90813, United States
Unknown Facility
Los Angeles, California, 90048, United States
Unknown Facility
Murrieta, California, 30060, United States
Unknown Facility
San Diego, California, 92121, United States
Unknown Facility
Chiefland, Florida, 32626, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Jupiter, Florida, 33458, United States
Unknown Facility
Largo, Florida, 33770, United States
Unknown Facility
Naples, Florida, 34104, United States
Unknown Facility
Ocala, Florida, 34471, United States
Unknown Facility
Ormond Beach, Florida, 32174, United States
Unknown Facility
Spring Hill, Florida, 34609, United States
Unknown Facility
Chicago, Illinois, 60610, United States
Unknown Facility
Indianapolis, Indiana, 46250, United States
Unknown Facility
Sunset, Louisiana, 70584, United States
Unknown Facility
Elkridge, Maryland, 21075, United States
Unknown Facility
Brockton, Massachusetts, 2301, United States
Unknown Facility
Cadillac, Michigan, 49601, United States
Unknown Facility
Traverse City, Michigan, 49684, United States
Unknown Facility
Biloxi, Mississippi, 39531, United States
Unknown Facility
Ocean Springs, Mississippi, 39564, United States
Unknown Facility
Las Vegas, Nevada, 89119, United States
Unknown Facility
Albuquerque, New Mexico, 87102, United States
Unknown Facility
Charlotte, North Carolina, 28204, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Dayton, Ohio, 45439, United States
Unknown Facility
Toledo, Ohio, 43623, United States
Unknown Facility
Medford, Oregon, 97504, 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
Dallas, Texas, 75230, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Alexandria, Virginia, 22304, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2007
First Posted
October 22, 2007
Study Start
October 1, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
August 20, 2020
Results First Posted
August 20, 2020
Record last verified: 2020-08