Clinical trial NCT00463047: Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Pain
Keywords: Breakthrough pain
Opioid-tolerant
Chronic pain
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2007-04-19
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity Difference (PID15) At 15 Minutes
timeFrame: Immediately pre-dose and fifteen minutes after administration of study drug
Secondary outcomes:
measure: Pain Intensity Difference (PID 5) at 5 Minutes
timeFrame: Immediately before and 5 minutes after study drug administration
measure: Pain Intensity Difference (PID 10) at 10 Minutes
timeFrame: Immediately before and 10 minutes after administration of study drug
measure: Pain Intensity Difference (PID 30) at 30 Minutes
timeFrame: Immediately before and 10 minutes after study drug administration
measure: Pain Intensity Difference (PID 45) at 45 Minutes
timeFrame: Immediately before and 45 minutes after study drug administration
measure: Pain Intensity Difference (PID 60) at 60 Minutes
timeFrame: Immediately before and 60 minutes after administration of study drug
measure: Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment
timeFrame: Immediately before and 5 minutes after administration of study drug
measure: Percentage Change in Pain Intensity Difference (%PID) at 10 Minutes
timeFrame: Immediately before and 10 minutes after study drug administration
measure: Percentage Change in Pain Intensity Difference (%PID) at 15 Minutes
timeFrame: Immediately before and 15 minutes after administration of study drug
measure: Percentage Change in Pain Intensity Difference (%PID) at 30 Minutes
timeFrame: Immediately before and 30 minutes after study drug administration
measure: Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes
timeFrame: Immediately before and 45 minutes after study drug administration
measure: Percentage Change in Pain Intensity Difference (%PID) at 60 Minutes
timeFrame: Immediately before and 60 minutes after study drug administration
measure: Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)
timeFrame: From 5 minutes after dosing through 30 minutes after dosing
measure: Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)
timeFrame: From 5 minutes after dosing through 60 minutes after dosing
measure: Pain Relief (PR) Score at 5 Minutes
timeFrame: Five minutes after administration of study drug
measure: Pain Relief Score (PR) at 10 Minutes
timeFrame: 10 minutes after treatment with study drug
measure: Pain Relief Score (PR) at 15 Minutes
timeFrame: 15 minutes after treatment with study drug
measure: Pain Relief Score (PR) at 30 Minutes
timeFrame: 30 minutes after treatment with study drug
measure: Pain Relief Score (PR) at 45 Minutes
timeFrame: 45 minutes after treatment with study drug
measure: Pain Relief Score (PR) at 60 Minutes
timeFrame: 60 minutes after treatment with study drug
measure: Total Pain Relief (TOTPAR60) at 60 Minutes
timeFrame: From 5 minutes to 60 minutes after dosing
measure: Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)
timeFrame: From 5 minutes through 60 minutes after study drug treatment
measure: Time to Any Pain Relief (APR) by Treatment, <= 5 Minutes
timeFrame: From time was administered to 5 minutes after treatment
measure: Time to Any Pain Relief (APR) by Treatment, <=10 Minutes
timeFrame: From study drug treatment until 10 minutes after treatment
measure: Time to Any Pain Relief (APR) by Treatment, <=15 Minutes
timeFrame: From study drug administration to 15 minutes after treatment
measure: Time to Any Pain Relief (APR) by Treatment, <=30 Minutes
timeFrame: Time of study drug administration till 30 minutes after treatment
measure: Time to Any Pain Relief (APR) by Treatment, <=45 Minutes
timeFrame: Time of study drug treatment until 45 minutes after treatment
measure: Time to Any Pain Relief (APR) by Treatment, <=60 Minutes
timeFrame: Time of study drug treatment until 60 minutes after treatment
measure: Time to Meaningful Pain Relief (MPR) by Treatment, <= 5 Minutes
timeFrame: From time study drug was taken until 5 minutes after treatment
measure: Time to Meaningful Pain Relief (MPR) by Treatment, <=10 Minutes
timeFrame: Time of study drug treatment until 10 minutes after treatment
measure: Time to Meaningful Pain Relief (MPR) by Treatment, <=15 Minutes
timeFrame: Time of study drug administration until 15 minutes after treatment
measure: Time to Meaningful Pain Relief (MPR) by Treatment, <=30 Minutes
timeFrame: Time of study drug administration until 30 minutes after treatment
measure: Time to Meaningful Pain Relief (MPR) by Treatment, <=45 Minutes
timeFrame: From study drug administration until 45 minutes after treatment
measure: Time to Meaningful Pain Relief (MPR) by Treatment, <=60 Minutes
timeFrame: Time of study drug administration until 60 minutes after treatment
measure: Standard Rescue Medication Usage
timeFrame: During the administration of study drug during the double blind treatment periods.
measure: Medication Performance Assessment 30 Minutes After-treatment
timeFrame: 30 minutes post-treatment
measure: Medication Performance Assessment 60 Minutes After-treatment
timeFrame: 60 minutes post-treatment
measure: Breakthrough Pain Preference Questionnaire
timeFrame: After completion of both double-blind treatment periods or early termination
measure: Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the First Double-blind Treatment Period (Visit 5)
timeFrame: The end of the first double-blind treatment period.
measure: Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the Second Double-blind Treatment Period (Visit 6)
timeFrame: At the end of the second double-blind treatment period (Visit 6)
measure: 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)
timeFrame: Endpoint (End of second double-blind treatment period or last observation after start of treatment period)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Birmingham
country: United States
facility: Birmingham Pain Center
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Phoenix
country: United States
facility: Desert Pain & Rehab Specialists/Redpoint Research
state: Arizona
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Beverly Hills
country: United States
facility: Lovelace Scientific Resources, Inc.
state: California
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Gatos
country: United States
facility: Samaritan Center for Medical Research, Med. Group
state: California
city: New Haven
country: United States
facility: Advanced Diagnostic Pain Treatment Center, PC
state: Connecticut
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Port Orange
country: United States
facility: AvivoClin Clinical Services
state: Florida
city: Sarasota
country: United States
facility: Lovelace Scientific Resources, Inc.
state: Florida
city: Spring Hill
country: United States
facility: Clinical Research of Tampa Bay, Inc.
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials, LLC
state: Florida
city: Atlanta
country: United States
facility: Center for Prospective Outcome Studies, Inc.
state: Georgia
city: Dawnsonville
country: United States
facility: North Georgia Premier Research
state: Georgia
city: Marietta
country: United States
facility: Taylor Research, LLC
state: Georgia
city: Marietta
country: United States
facility: DrugStudies America
state: Georgia
city: Evansville
country: United States
facility: Tristate Arthritis & Rheumatology Center, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Rehabilitation Associates of Indiana
state: Indiana
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services, Inc.
state: Iowa
city: Overland Park
country: United States
facility: International Clinical Research Institute, Inc.
state: Kansas
city: Overland Park
country: United States
facility: Kansas City Bone & Joint Clinic, Inc.
state: Kansas
city: Shreveport
country: United States
facility: Willis-Knighton Pain Management Center
state: Louisiana
city: Baltimore
country: United States
facility: The Rehabilitation Team West
state: Maryland
city: Pikesville
country: United States
facility: Mid Atlantic Pain Medicine Center
state: Maryland
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources, Inc.
state: New Mexico
city: New York
country: United States
facility: Metropolitan Hospital Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associate
state: North Carolina
city: Columbus
country: United States
facility: Columbus Clinical Research
state: Ohio
city: Altoona
country: United States
facility: Allegheny Pain Management
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Pharmaceutical
state: South Carolina
city: Hendersonville
country: United States
facility: Comprehensive Pain Specialists, PLLC
state: Tennessee
city: San Antonio
country: United States
facility: Consultants in Pain Research
state: Texas
city: San Antonio
country: United States
facility: InVisions Consultants, LLC
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Charleston
country: United States
facility: The Center for Pain Relief
state: West Virginia
Study officials:
References: