Clinical trial NCT00801398: Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
Official title: An Open-Label, Ascending, Two-Part, Single- and Multiple-Dose Evaluation of the Safety, Pharmacokinetics, and Effectiveness of Oxymorphone for Acute Postoperatiave Pain in Pediatric Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: Opioid tolerant
Pediatric
Pain
Non malignant
Malignant
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-12-03
Enrollment: 58
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40).

This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.


Eligibility criteria: Inclusion Criteria:

* Male or female \> 12 to 17 years of age, inclusive
* Weigh at least 50 kg
* Postoperative oral opioid analgesia required for at least 24 hours or 48 hours following postoperataive parenteral analgesia
* Are expected to be hospitalized for the duration of the study

Exclusion Criteria:

* Known allergy to, or a significant reaction to, oxymorphone or another opioid
* Life expectancy of \< 4 weeks
* Positive pregnancy test at screening

Primary outcomes:
measure: Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet
timeFrame: Single Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h or Rescue; Multiple Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h, subsequent doses every 4-6 hours (Multiple Dose #1-11), and Early Termination
measure: Subjects Taking Rescue Medication
timeFrame: first dose through 48 hours after first dose
Secondary outcomes:
measure: AUC(0-t) of Single Dose of Oxymorphone by Treatment Group
timeFrame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
measure: AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group
timeFrame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
measure: Cmax of Single Dose of Oxymorphone by Treatment Group
timeFrame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
measure: Tmax of Single Dose of Oxymorphone by Treatment Group
timeFrame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
measure: Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group
timeFrame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
measure: Terminal Half-life of Single Dose of Oxymorphone by Treatment Group
timeFrame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
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: Washington
country: United States
facility: Children's Research Institute
state: District of Columbia
city: Tampa
country: United States
facility: St. Joseph's Children's Hospital of Tampa
state: Florida
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: The Children's Hospital of Pittsburgh
state: Pennsylvania
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Endo Pharmaceuticals
name: Study Director
role: STUDY_DIRECTOR
References: