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

Endo Pharmaceuticals

Status and phase

Terminated

Phase 3

Conditions

Chronic Pain

Treatments

Drug: Oxymorphone ER

Study type

Interventional

Funder types

Industry

Identifiers

NCT00765856

EN3202 036

Details and patient eligibility

About

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.

Full description

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

Enrollment

27 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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