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

This study has been terminated.

( Terminated new protocol developed which incorporated Pharmacokinetics )

First Received on October 2, 2008. Last Updated on June 6, 2011 History of Changes

Sponsor:	Endo Pharmaceuticals
Information provided by:	Endo Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00765856

Purpose

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	Intervention	Phase
Chronic Pain	Drug: Oxymorphone ER - Opioid	Phase III

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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.

Resource links provided by NLM:

Drug Information available for: Oxymorphone Oxymorphone hydrochloride

U.S. FDA Resources

Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Assessment of AEs, vital signs, and physical examinations. [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	October 2008
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: No arms Open-label	Drug: Oxymorphone ER - Opioid Tablet form taken q12 hours Other Name: Opana® ER

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765856

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

No publications provided

Responsible Party:	Sr. Director Clinical R&D, Endo Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00765856 History of Changes
Other Study ID Numbers:	EN3202 036
Study First Received:	October 2, 2008
Last Updated:	June 6, 2011
Health Authority:	United States: Food and Drug Administration

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:

Oxymorphone
Analgesics, Opioid
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012