Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects

Study Description

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Brief Summary:

Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosing adjustments will be based on the review of the subject's pain scores. Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain medication (as needed). Titration Period will end when the fixed dose of study medication is tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the open-label 3-month maintenance period on the fixed dose of study medication established during the Titration Period.

Condition or disease	Intervention/treatment	Phase
Chronic Pain	Drug: Oxymorphone IR - Opioid	Phase 3

Detailed Description:

An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	27 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.
Study Start Date :	October 2008
Actual Primary Completion Date :	February 2010
Actual Study Completion Date :	February 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Opana® ER; Oxymorphone IR - Opioid	Drug: Oxymorphone IR - Opioid; Opana IR 5mg tablet; Other Name: Opana®

Outcome Measures

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Primary Outcome Measures :

1. Change in pain intensity from baseline to last assessment using the FPS-R. [ Time Frame: From baseline up to 4 weeks ]

Secondary Outcome Measures :

1. Assessment of AEs, vital signs, and physical examinations. [ Time Frame: Duration of the study ]

Eligibility Criteria

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Ages Eligible for Study:	6 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Have chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose greater than or equal to 45 mg/daily (qd) oral morphine equivalent)
• 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:

• Have a life expectancy <4 weeks
• 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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Arkansas
Arkansas Childrens's Hospital-Division of Pediatric Anestesia and Pain Medicine
Little Rock, Arkansas, United States, 72202
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Colorado
The Children's Hospital
Aurora, Colorado, United States, 80045
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Florida Institute of Medical Research
Jacksonville, Florida, United States, 32257
Tukoi Clinical Research
Miami, Florida, United States, 34104
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States, 33618
United States, Georgia
Taylor Research, LLC
Marietta, Georgia, United States, 30060
United States, Indiana
Rehabilitation Associates of Indiana
Indianapolis, Indiana, United States, 46250
United States, Kentucky
University of Louisville Reserach Foundation, Inc.
Louisville, Kentucky, United States, 40202
United States, North Carolina
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17112

Sponsors and Collaborators

Endo Pharmaceuticals

Investigators

Study Director:	Sr. Director CR&D	Endo Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Endo Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00765856 History of Changes
Other Study ID Numbers:	EN3202 036
First Posted:	October 3, 2008
Last Update Posted:	June 12, 2015
Last Verified:	June 2015

Keywords provided by Endo Pharmaceuticals:

Opioid tolerant; Pediatric; Male 6-17 years of age; Female 6-17 years of age	Pain; Non malignant; Malignant

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Analgesics, Opioid; Oxymorphone	Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adjuvants, Anesthesia