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Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain
This study has been completed.
First Received: February 8, 2007   Last Updated: February 27, 2009   History of Changes
Sponsor: Cephalon
Information provided by: Cephalon
ClinicalTrials.gov Identifier: NCT00463047
  Purpose

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.


Condition Intervention Phase
Chronic Pain
Drug: Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment
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

Resource links provided by NLM:


Further study details as provided by Cephalon:

Primary Outcome Measures:
  • To evaluate the efficacy of FBT compared with immediate-release oxycodone in alleviating BTP in patients with chronic pain as assessed by the pain intensity (PI) difference (PID) 15 minutes after the administration of study drug. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety and tolerability of FBT treatment compared with immediate-release oxycodone [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 324
Study Start Date: June 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: 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).
Drug: Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone
Patients will be randomly assigned in a 1:1 ratio either to titrate immediate-release oxycodone first and to titrate FBT second, or to titrate FBT first and immediate-release oxycodone second.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 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 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 (ie, the 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 UDS for an illicit drug or a medication not prescribed for him/her or which is not medically explainable.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463047

  Hide Study Locations
Locations
United States, Alabama
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
Birmingham Pain Center
Birmingham, Alabama, United States, 35244
United States, Arizona
Desert Pain & Rehab Specialists/Redpoint Research
Phoenix, Arizona, United States, 85029
Hope Research Institute
Phoenix, Arizona, United States, 85050
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, California
Samaritan Center for Medical Research, Med. Group
Los Gatos, California, United States, 95032
Lovelace Scientific Resources, Inc.
Beverly Hills, California, United States, 90211
City of Hope National Medical Center
Duarte, California, United States, 91010
United States, Connecticut
Advanced Diagnostic Pain Treatment Center, PC
New Haven, Connecticut, United States, 06511
United States, Florida
Lovelace Scientific Resources, Inc.
Sarasota, Florida, United States, 34233
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Compass Research
Orlando, Florida, United States, 32806
Stedman Clinical Trials, LLC
Tampa, Florida, United States, 33613
Clinical Research of Tampa Bay, Inc.
Spring Hill, Florida, United States, 34609
AvivoClin Clinical Services
Port Orange, Florida, United States, 32127
United States, Georgia
DrugStudies America
Marietta, Georgia, United States, 30066
Taylor Research, LLC
Marietta, Georgia, United States, 30060
Center for Prospective Outcome Studies, Inc.
Atlanta, Georgia, United States, 30327
North Georgia Premier Research
Dawnsonville, Georgia, United States, 30534
United States, Indiana
Rehabilitation Associates of Indiana
Indianapolis, Indiana, United States, 46250
Tristate Arthritis & Rheumatology Center, LLC
Evansville, Indiana, United States, 47714
United States, Iowa
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, United States, 50265
United States, Kansas
International Clinical Research Institute, Inc.
Overland Park, Kansas, United States, 66211
Kansas City Bone & Joint Clinic, Inc.
Overland Park, Kansas, United States, 66211
United States, Louisiana
Willis-Knighton Pain Management Center
Shreveport, Louisiana, United States, 71103
United States, Maryland
Mid Atlantic Pain Medicine Center
Pikesville, Maryland, United States, 21208
The Rehabilitation Team West
Baltimore, Maryland, United States, 21228
United States, New Jersey
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
United States, New Mexico
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, United States, 87108
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Metropolitan Hospital Center
New York, New York, United States, 10029
United States, North Carolina
PharmQuest
Greensboro, North Carolina, United States, 27401
Raleigh Neurology Associate
Raleigh, North Carolina, United States, 27607
Peters Medical Research
High Point, North Carolina, United States, 27262
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Columbus Clinical Research
Columbus, Ohio, United States, 43213
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19146
Allegheny Pain Management
Altoona, Pennsylvania, United States, 16602
United States, South Carolina
Greenville Pharmaceutical
Greenville, South Carolina, United States, 29615
United States, Tennessee
Comprehensive Pain Specialists, PLLC
Hendersonville, Tennessee, United States, 37075
United States, Texas
Consultants in Pain Research
San Antonio, Texas, United States, 78209
InVisions Consultants, LLC
San Antonio, Texas, United States, 78218
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98004
United States, West Virginia
The Center for Pain Relief
Charleston, West Virginia, United States, 25301
Sponsors and Collaborators
Cephalon
  More Information

No publications provided

Responsible Party: Cephalon ( Sponsor's Medical Expert )
Study ID Numbers: C25608/3055/BP/MN
Study First Received: February 8, 2007
Last Updated: February 27, 2009
ClinicalTrials.gov Identifier: NCT00463047     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Cephalon:
Breakthrough pain
Opioid-tolerant
Chronic pain

Additional relevant MeSH terms:
Anesthetics, Intravenous
Fentanyl
Nervous System Diseases
Oxycodone
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pain
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia
Signs and Symptoms
Anesthetics, General
Sensory System Agents
Therapeutic Uses
Neurologic Manifestations
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 22, 2009