Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
NCT ID: NCT00765856
Last Updated: 2020-12-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
27 participants
INTERVENTIONAL
2008-11-17
2010-02-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Oxymorphone ER
Oxymorphone ER
Oxymorphone ER dosing adjustments made under the direction of the Investigator during the Titration Period.
Oxymorphone IR (Opana) IR 5mg tablet - used as rescue medications
Interventions
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Oxymorphone ER
Oxymorphone ER dosing adjustments made under the direction of the Investigator during the Titration Period.
Oxymorphone IR (Opana) IR 5mg tablet - used as rescue medications
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Weigh at least 50 kg
* Expected to continue to require a strong opioid for pain relief for at least 4 weeks and up to 4 months.
Exclusion Criteria
* Plan to undergo a surgical procedure within 3 days of study entry or during the Titration Period
* Have dysphagia or difficulty swallowing whole tablets
* Have a previous exposure to oxymorphone
* Have an ileostomy
6 Years
17 Years
ALL
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Sr. Director CR&D
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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Arkansas Childrens's Hospital-Division of Pediatric Anestesia and Pain Medicine
Little Rock, Arkansas, United States
Stanford University School of Medicine
Stanford, California, United States
The Children's Hospital
Aurora, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Florida Institute of Medical Research
Jacksonville, Florida, United States
Tukoi Clinical Research
Miami, Florida, United States
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States
Taylor Research, LLC
Marietta, Georgia, United States
Rehabilitation Associates of Indiana
Indianapolis, Indiana, United States
University of Louisville Reserach Foundation, Inc.
Louisville, Kentucky, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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Other Identifiers
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EN3202 036
Identifier Type: -
Identifier Source: org_study_id
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