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

Stopped early · Phase 3

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID

NCT00765856

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

27

Starts

2008-11-17

Expected to finish

2010-02-22

Last updated by the study team

2020-12-16

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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