drugset / Trial / NCT00813488

Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for Breakthrough Pain in Patients With Chronic Pain

NCT00813488 ↗

Phase 3 Completed 213 enrolled Cephalon
RandomizedCrossoverQuadruple-blindTreatment

Summary

Evaluate the efficacy of treatment with the fentanyl buccal tablet (FBT) compared with immediate release oxycodone treatment in alleviating breakthrough pain (BTP) in opioid tolerant patients with chronic pain.

Timeline

Start
2008-12
Primary completion
2009-11
Completion
2010-01

Outcome

Met primary endpoint

paper PI difference at 15 minutes (mean [standard deviation]) was greater with fentanyl buccal tablet (0.88 [1.20]) vs oxycodone (0.76 [1.13]; P < 0.001). PMID 23855816 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Fentanyl Other / unclassified 200 ug —
Subject Fentanyl Other / unclassified 400 ug —
Subject Fentanyl Other / unclassified 600 ug —
Subject Fentanyl Other / unclassified 800 ug —
Subject Oxycodone Other / unclassified 15 mg —
Subject Oxycodone Other / unclassified 30 mg —
Subject Oxycodone Other / unclassified 45 mg —
Subject Oxycodone Other / unclassified 60 mg —

Indications