CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 213 enrolled
Drug / intervention
Fentanyl Buccal Tablet +1 moredrug
Likely dose
Fentanyl Buccal Tablet 800 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00813488
NCT00813488Phase 3Completed
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A Double Blind, Active Controlled Crossover Study to Evaluate the Efficacy and Safety of Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for the Management of Breakthrough Pain in Opioid Tolerant Patients With Chronic Pain

Cephalon·interventional·Posted Dec 23, 2008·Updated May 28, 2012

In Brief

A Phase 3 clinical trial evaluating Fentanyl Buccal Tablet and Immediate release oxycodone for Chronic Pain. Completed, enrolled 213 participants across 50 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 23, 2008
Enrollment StartDec 1, 2008
Primary CompletionNov 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.5 years ago

Interventions

Fentanyl Buccal Tabletdrug

FBT dose strengths = 200, 400, 600, or 800 mcg (1, 2, 3, or 4 tablets) taken prn (as needed) in the event of breakthrough pain. The maximum dose of FBT permitted during the titration and double-blind periods in this study is 800 mcg (4 tablets). For the subsequent 12-week open-label treatment period, patients will either continue with FBT treatment or begin treatment with an alternative short-acting opioid deemed appropriate for each patient by the clinician.

Immediate release oxycodonedrug

Immediate release oxycodone dosage strength: 15, 30, 45, and 60 mg doses (1, 2, 3 or 4 capsules) to be taken prn (as needed) for breakthrough pain. The maximum single dose would be 60 mg (4 capsules).