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

Condition(s) targeted: Chronic Pain

Intervention: Oxymorphone ER - Opioid (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Endo Pharmaceuticals

Official(s) and/or principal investigator(s):
Sr. Director CR&D, Study Director, Affiliation: Endo Pharmaceuticals

Overall contact:
Clinical Project Manager, Phone: 1-877-329-3636, Email: clinicaltrials@endo.com

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.

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 design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Change in pain intensity from baseline to last assessment using the FPS-R.

Secondary outcome: Assessment of AEs, vital signs, and physical examinations.

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

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

Clinical Project Manager, Phone: 1-877-329-3636, Email: clinicaltrials@endo.com

Arkansas Childrens's Hospital-Division of Pediatric Anestesia and Pain Medicine, Little Rock, Arkansas 72202, United States; Recruiting
Email: clinicaltrials@endo.com

Stanford University School of Medicine, Stanford, California 94305, United States; Recruiting
Email: clinicaltrials@endo.com

The Children's Hospital, Aurora, Colorado 80045, United States; Recruiting
Email: clinicaltrials@endo.com

Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States; Recruiting
Email: clinicaltrials@endo.com

Children's National Medical Center, Washington, District of Columbia 20010, United States; Recruiting
Email: clinicaltrials@endo.com

St. Joseph's Children's Hospital of Tampa, Tampa, Florida 33618, United States; Recruiting
Email: clinicaltrials@endo.com

Tukoi Clinical Research, Miami, Florida 34104, United States; Recruiting
Email: clinicaltrials@endo.com

Florida Institute of Medical Research, Jacksonville, Florida 32257, United States; Recruiting
Email: clinicaltrials@endo.com

Taylor Research, LLC, Marietta, Georgia 30060, United States; Recruiting
Email: clinicaltrials@endo.com

Rehabilitation Associates of Indiana, Indianapolis, Indiana 46250, United States; Recruiting
Email: clinicaltrials@endo.com

University of Louisville Reserach Foundation, Inc., Louisville, Kentucky 40202, United States; Recruiting
Email: clinicaltrials@endo.com

The Center for Clinical Research, Winston-Salem, North Carolina 27103, United States; Recruiting
Email: clinicaltrials@endo.com

Hershey Medical Center, Hershey, Pennsylvania 17112, United States; Recruiting
Email: clinicaltrials@endo.com

Starting date: October 2008
Ending date: December 2010
Last updated: October 16, 2009