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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 Minutes

Pain 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

Page last updated: August 23, 2015

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