Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
- Registration Number
- NCT00765856
- Lead Sponsor
- Endo Pharmaceuticals
- 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.
- Detailed Description
An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 27
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Oxymorphone ER Oxymorphone ER -
- Primary Outcome Measures
Name Time Method Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
- Secondary Outcome Measures
Name Time Method Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) Average number of daily rescues per day by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) Total number of doses (Tablets) taken by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Trial Locations
- Locations (13)
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
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
The Children's Hospital
🇺🇸Aurora, Colorado, United States
Children's National Medical Center
🇺🇸Washington, 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