MedTrace Logo

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

NCT00813488 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2012-05-28

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Fentanyl Buccal Tablet

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.

DRUG

Immediate release oxycodone

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).

Sponsors & Collaborators

  • Cephalon

    lead INDUSTRY

Principal Investigators

  • Sponsor's Medical Expert, MD · Cephalon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-11-30
Completion
2010-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00813488 on ClinicalTrials.gov