Clinical trial NCT00765856: Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Pain
Keywords: Opioid tolerant
Pediatric
Male 6-17 years of age
Female 6-17 years of age
Pain
Non malignant
Malignant
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-10-03
Enrollment: 27
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose
timeFrame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Secondary outcomes:
measure: Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken
timeFrame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
measure: Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose
timeFrame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
measure: Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues
timeFrame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
measure: Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses
timeFrame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Childrens's Hospital-Division of Pediatric Anestesia and Pain Medicine
state: Arkansas
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Aurora
country: United States
facility: The Children's Hospital
state: Colorado
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Florida Institute of Medical Research
state: Florida
city: Miami
country: United States
facility: Tukoi Clinical Research
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Children's Hospital of Tampa
state: Florida
city: Marietta
country: United States
facility: Taylor Research, LLC
state: Georgia
city: Indianapolis
country: United States
facility: Rehabilitation Associates of Indiana
state: Indiana
city: Louisville
country: United States
facility: University of Louisville Reserach Foundation, Inc.
state: Kentucky
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Endo Pharmaceuticals
name: Sr. Director CR&D
role: STUDY_DIRECTOR
References: