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A Randomized, Double-Blind, Active-Controlled Crossover Study to Evaluate the Efficacy and Safety of Fentanyl Buccal Tablets Compared With Immediate-release Oxycodone for the Management of Breakthrough Pain in Opioid-Tolerant Patient With Chronic Pain
Evaluate the efficacy of treatment with Fentanyl Buccal Tablets (FBT) compared with immediate release oxycodone in alleviating breakthrough pain in opioid tolerant patients with chronic pain.
Details
| Lead sponsor | Cephalon |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 323 |
| Start date | 2007-07 |
| Completion | 2009-02 |
Conditions
- Chronic Pain
Interventions
- Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone
Primary outcomes
- Pain Intensity Difference (PID15) At 15 Minutes — Immediately pre-dose and fifteen minutes after administration of study drug
Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Countries
United States