Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain
Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Pain
Intervention: Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Cephalon
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.
Clinical Details
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 design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Pain Intensity Difference (PID15) At 15 Minutes
Secondary outcome: Pain Intensity Difference (PID 5) at 5 MinutesPain Intensity Difference (PID 10) at 10 Minutes Pain Intensity Difference (PID 30) at 30 Minutes Pain Intensity Difference (PID 45) at 45 Minutes Pain Intensity Difference (PID 60) at 60 Minutes Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment Percentage Change in Pain Intensity Difference (%PID) at 10 Minutes Percentage Change in Pain Intensity Difference (%PID) at 15 Minutes Percentage Change in Pain Intensity Difference (%PID) at 30 Minutes Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes Percentage Change in Pain Intensity Difference (%PID) at 60 Minutes Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30) Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60) Pain Relief (PR) Score at 5 Minutes Pain Relief Score (PR) at 10 Minutes Pain Relief Score (PR) at 15 Minutes Pain Relief Score (PR) at 30 Minutes Pain Relief Score (PR) at 45 Minutes Pain Relief Score (PR) at 60 Minutes Total Pain Relief (TOTPAR60) at 60 Minutes Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR) Time to Any Pain Relief (APR) by Treatment, <= 5 Minutes Time to Any Pain Relief (APR) by Treatment, <=10 Minutes Time to Any Pain Relief (APR) by Treatment, <=15 Minutes Time to Any Pain Relief (APR) by Treatment, <=30 Minutes Time to Any Pain Relief (APR) by Treatment, <=45 Minutes Time to Any Pain Relief (APR) by Treatment, <=60 Minutes Time to Meaningful Pain Relief (MPR) by Treatment, <= 5 Minutes Time to Meaningful Pain Relief (MPR) by Treatment, <=10 Minutes Time to Meaningful Pain Relief (MPR) by Treatment, <=15 Minutes Time to Meaningful Pain Relief (MPR) by Treatment, <=30 Minutes Time to Meaningful Pain Relief (MPR) by Treatment, <=45 Minutes Time to Meaningful Pain Relief (MPR) by Treatment, <=60 Minutes Standard Rescue Medication Usage Medication Performance Assessment 30 Minutes After-treatment Medication Performance Assessment 60 Minutes After-treatment Breakthrough Pain Preference Questionnaire Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the First Double-blind Treatment Period (Visit 5) Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 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)
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
Alabama Clinical Therapeutics, Birmingham, Alabama 35235, United States
Birmingham Pain Center, Birmingham, Alabama 35244, United States
Arizona Research Center, Phoenix, Arizona 85023, United States
Desert Pain & Rehab Specialists/Redpoint Research, Phoenix, Arizona 85029, United States
Hope Research Institute, Phoenix, Arizona 85050, United States
Lovelace Scientific Resources, Inc., Beverly Hills, California 90211, United States
City of Hope National Medical Center, Duarte, California 91010, United States
Samaritan Center for Medical Research, Med. Group, Los Gatos, California 95032, United States
Advanced Diagnostic Pain Treatment Center, PC, New Haven, Connecticut 06511, United States
Jacksonville Center for Clinical Research, Jacksonville, Florida 32216, United States
Compass Research, Orlando, Florida 32806, United States
AvivoClin Clinical Services, Port Orange, Florida 32127, United States
Lovelace Scientific Resources, Inc., Sarasota, Florida 34233, United States
Clinical Research of Tampa Bay, Inc., Spring Hill, Florida 34609, United States
Stedman Clinical Trials, LLC, Tampa, Florida 33613, United States
Center for Prospective Outcome Studies, Inc., Atlanta, Georgia 30327, United States
North Georgia Premier Research, Dawnsonville, Georgia 30534, United States
DrugStudies America, Marietta, Georgia 30066, United States
Taylor Research, LLC, Marietta, Georgia 30060, United States
Tristate Arthritis & Rheumatology Center, LLC, Evansville, Indiana 47714, United States
Rehabilitation Associates of Indiana, Indianapolis, Indiana 46250, United States
Integrated Clinical Trial Services, Inc., West Des Moines, Iowa 50265, United States
International Clinical Research Institute, Inc., Overland Park, Kansas 66211, United States
Kansas City Bone & Joint Clinic, Inc., Overland Park, Kansas 66211, United States
Willis-Knighton Pain Management Center, Shreveport, Louisiana 71103, United States
The Rehabilitation Team West, Baltimore, Maryland 21228, United States
Mid Atlantic Pain Medicine Center, Pikesville, Maryland 21208, United States
Englewood Hospital and Medical Center, Englewood, New Jersey 07631, United States
Lovelace Scientific Resources, Inc., Albuquerque, New Mexico 87108, United States
Metropolitan Hospital Center, New York, New York 10029, United States
Mount Sinai School of Medicine, New York, New York 10029, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
PharmQuest, Greensboro, North Carolina 27401, United States
Peters Medical Research, High Point, North Carolina 27262, United States
Raleigh Neurology Associate, Raleigh, North Carolina 27607, United States
Columbus Clinical Research, Columbus, Ohio 43213, United States
Allegheny Pain Management, Altoona, Pennsylvania 16602, United States
Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States
University of Pennsylvania, Philadelphia, Pennsylvania 19146, United States
Greenville Pharmaceutical, Greenville, South Carolina 29615, United States
Comprehensive Pain Specialists, PLLC, Hendersonville, Tennessee 37075, United States
Consultants in Pain Research, San Antonio, Texas 78209, United States
InVisions Consultants, LLC, San Antonio, Texas 78218, United States
Northwest Clinical Research Center, Bellevue, Washington 98004, United States
The Center for Pain Relief, Charleston, West Virginia 25301, United States
Additional Information
Starting date: July 2007
Last updated: May 22, 2012
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