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Clinical Trials/NCT00463047
NCT00463047CompletedPhase 3

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

Cephalon43 sites in 1 country323 target enrollmentStarted: July 2007Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
323
Locations
43
Primary Endpoint
Pain Intensity Difference (PID15) At 15 Minutes
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •The patient has chronic pain of at least 3 months duration associated with: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain,fibromyalgia, chronic pancreatitis, osteoarthritis,or cancer.
  • •The patient is currently using 1 of the following: at least 60 mg of oral morphine/day, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oxycodone/day, or at least 8 mg of hydromorphone/day, or an equianalgesic dose of another opioid/day as around-the-clock (ATC) therapy for at least 7 days before administration of the first dose of study drug
  • •The patient is willing to provide written informed consent to participate in this study.
  • •The patient is 18 through 80 years of age.
  • •Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, using a medically accepted method of birth control and agree to continued use of this method for the duration of the study.
  • •Any patient with cancer should have a life expectancy of at least 3 months.
  • •The patient reports an average Pain Intensity (PI) score, over the prior 24 hours, of 6 or less (0=no pain through 10=pain as bad as you can imagine) for their chronic pain.
  • •The patient experiences, on average, 1 to 4 breakthrough pain (BTP) episodes per day while taking ATC opioid therapy, and on average, the duration of each BTP episode is less than 4 hours.
  • •The patient currently uses opioid therapy for alleviation of BTP episodes, occurring at the location of the chronic pain, and achieves at least partial relief.
  • •The patient must be willing and able to successfully self-administer the study drug,comply with study restrictions, complete the electronic diary, and return to the clinic for scheduled study visits as specified in this protocol.

Exclusion Criteria

  • •The patient has uncontrolled or rapidly escalating pain as determined by the investigator (i.e., the around-the-clock (ATC) therapy may be expected to change between the first and last treatments with study drug), or has pain uncontrolled by therapy that could adversely impact the safety of the patient or that could be compromised by treatment with study drug.
  • •The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse.
  • •The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in either study drug.
  • •The patient has cardiopulmonary disease that would, in the opinion of the investigator, significantly increase the risk of treatment with potent synthetic opioids.
  • •The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data.
  • •The patient is expected to have surgery during the study that will impact the patient's chronic pain and/or BTP.
  • •The patient has had therapy before study drug treatment that, in the opinion of the investigator, could alter pain or response to pain medication.
  • •The patient is pregnant or lactating.
  • •The patient has participated in a previous study with FBT.
  • •The patient has participated in a study involving an investigational drug in the prior 30 days.
  • •The patient is currently using prescription FBT or immediate-release oxycodone for BTP and is unwilling to undergo re-titration.
  • •The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug.
  • •The patient has any other medical condition or is receiving concomitant medication/therapy (eg, regional nerve block) that could, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol,or compromise collected data.
  • •The patient is involved in active litigation in regard to the chronic pain currently being treated.
  • •The patient has a positive urine drug screen (UDS) for an illicit drug or a medication not prescribed for him/her or which is not medically explainable.

Arms & Interventions

Fentanyl Buccal Tablets (FBT)

Experimental

This study includes a screening period, 2 open-label dose titration periods (in randomized order), and 2 double-blind treatment periods (in randomized order).

Intervention: Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone (Drug)

Oxycodone

Active Comparator

This study includes a screening period, 2 open-label dose titration periods (in randomized order), and 2 double-blind treatment periods (in randomized order).

Intervention: Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone (Drug)

Outcomes

Primary Outcomes

Pain Intensity Difference (PID15) At 15 Minutes

Time Frame: 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.

Secondary Outcomes

  • Pain Intensity Difference (PID 5) at 5 Minutes(Immediately before and 5 minutes after study drug administration)
  • Pain Intensity Difference (PID 10) at 10 Minutes(Immediately before and 10 minutes after administration of study drug)
  • Pain Intensity Difference (PID 30) at 30 Minutes(Immediately before and 10 minutes after study drug administration)
  • Pain Intensity Difference (PID 45) at 45 Minutes(Immediately before and 45 minutes after study drug administration)
  • Pain Intensity Difference (PID 60) at 60 Minutes(Immediately before and 60 minutes after administration of study drug)
  • Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment(Immediately before and 5 minutes after administration of study drug)
  • Percentage Change in Pain Intensity Difference (%PID) at 10 Minutes(Immediately before and 10 minutes after study drug administration)
  • Percentage Change in Pain Intensity Difference (%PID) at 15 Minutes(Immediately before and 15 minutes after administration of study drug)
  • Percentage Change in Pain Intensity Difference (%PID) at 30 Minutes(Immediately before and 30 minutes after study drug administration)
  • Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes(Immediately before and 45 minutes after study drug administration)
  • Percentage Change in Pain Intensity Difference (%PID) at 60 Minutes(Immediately before and 60 minutes after study drug administration)
  • Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)(From 5 minutes after dosing through 30 minutes after dosing)
  • Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)(From 5 minutes after dosing through 60 minutes after dosing)
  • Pain Relief (PR) Score at 5 Minutes(Five minutes after administration of study drug)
  • Pain Relief Score (PR) at 10 Minutes(10 minutes after treatment with study drug)
  • Pain Relief Score (PR) at 15 Minutes(15 minutes after treatment with study drug)
  • Pain Relief Score (PR) at 30 Minutes(30 minutes after treatment with study drug)
  • Pain Relief Score (PR) at 45 Minutes(45 minutes after treatment with study drug)
  • Pain Relief Score (PR) at 60 Minutes(60 minutes after treatment with study drug)
  • Total Pain Relief (TOTPAR60) at 60 Minutes(From 5 minutes to 60 minutes after dosing)
  • Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)(From 5 minutes through 60 minutes after study drug treatment)
  • Time to Any Pain Relief (APR) by Treatment, <= 5 Minutes(From time was administered to 5 minutes after treatment)
  • Time to Any Pain Relief (APR) by Treatment, <=10 Minutes(From study drug treatment until 10 minutes after treatment)
  • Time to Any Pain Relief (APR) by Treatment, <=15 Minutes(From study drug administration to 15 minutes after treatment)
  • Time to Any Pain Relief (APR) by Treatment, <=30 Minutes(Time of study drug administration till 30 minutes after treatment)
  • Time to Any Pain Relief (APR) by Treatment, <=45 Minutes(Time of study drug treatment until 45 minutes after treatment)
  • Time to Any Pain Relief (APR) by Treatment, <=60 Minutes(Time of study drug treatment until 60 minutes after treatment)
  • Time to Meaningful Pain Relief (MPR) by Treatment, <= 5 Minutes(From time study drug was taken until 5 minutes after treatment)
  • Time to Meaningful Pain Relief (MPR) by Treatment, <=10 Minutes(Time of study drug treatment until 10 minutes after treatment)
  • Time to Meaningful Pain Relief (MPR) by Treatment, <=15 Minutes(Time of study drug administration until 15 minutes after treatment)
  • Time to Meaningful Pain Relief (MPR) by Treatment, <=30 Minutes(Time of study drug administration until 30 minutes after treatment)
  • Time to Meaningful Pain Relief (MPR) by Treatment, <=45 Minutes(From study drug administration until 45 minutes after treatment)
  • Time to Meaningful Pain Relief (MPR) by Treatment, <=60 Minutes(Time of study drug administration until 60 minutes after treatment)
  • Standard Rescue Medication Usage(During the administration of study drug during the double blind treatment periods.)
  • Medication Performance Assessment 30 Minutes After-treatment(30 minutes post-treatment)
  • Medication Performance Assessment 60 Minutes After-treatment(60 minutes post-treatment)
  • Breakthrough Pain Preference Questionnaire(After completion of both double-blind treatment periods or early termination)
  • Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the First Double-blind Treatment Period (Visit 5)(The end of the first double-blind treatment period.)
  • Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the Second Double-blind Treatment Period (Visit 6)(At the end of the second double-blind treatment period (Visit 6))
  • Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at Endpoint (End of Second Double-blind Treatment Period or Last Observation After Start of Treatment Period)(Endpoint (End of second double-blind treatment period or last observation after start of treatment period))

Investigators

Sponsor
Cephalon
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (43)

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