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.
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.
Alabama Clinical Therapeutics, Birmingham, Alabama 35235, United States; Completed
Birmingham Pain Center, Birmingham, Alabama 35244, United States; Recruiting
Site Contact
Michael Gibson, MD, Principal Investigator
Desert Pain & Rehab Specialists/Redpoint Research, Phoenix, Arizona 85029, United States; Recruiting
Site Contact
Herbert Goodman, MD, Principal Investigator
Hope Research Institute, Phoenix, Arizona 85050, United States; Recruiting
Site Contact
Steven Siwek, MD, Principal Investigator
Arizona Research Center, Phoenix, Arizona 85023, United States; Recruiting
Site Contact
Joseph Gimbel, MD, Principal Investigator
Samaritan Center for Medical Research, Med. Group, Los Gatos, California 95032, United States; Recruiting
Site Contact
Maia Chakerian, MD, Principal Investigator
Lovelace Scientific Resources, Inc., Beverly Hills, California 90211, United States; Recruiting
Site Contact
Adam D. Karns, MD, Principal Investigator
City of Hope National Medical Center, Duarte, California 91010, United States; Completed
Northridge Pain Management Services, Northridge, California 91324, United States; Completed
Advanced Diagnostic Pain Treatment Center, PC, New Haven, Connecticut 06511, United States; Recruiting
Site Contact
Lloyd Saberski, MD, Principal Investigator
Lovelace Scientific Resources, Inc., Sarasota, Florida 34233, United States; Recruiting
Site Contact
Lora L. Brown, MD, Principal Investigator
Jacksonville Center for Clinical Research, Jacksonville, Florida 32216, United States; Recruiting
Site Contact
Shahriar Nabizadeh, MD, Principal Investigator
Compass Research, Orlando, Florida 32806, United States; Recruiting
Site Contact
Craig Curtis, MD, Principal Investigator
Stedman Clinical Trials, LLC, Tampa, Florida 33613, United States; Recruiting
Site Contact
Mary Stedman, MD, Principal Investigator
Clinical Research of Tampa Bay, Inc., Spring Hill, Florida 34609, United States; Recruiting
Site Contact
Michael Courtney, MD, Principal Investigator
DrugStudies America, Marietta, Georgia 30066, United States; Recruiting
Site Contact
Marvin Tark, MD, Principal Investigator
Taylor Research, LLC, Marietta, Georgia 30060, United States; Recruiting
Site Contact
Donald Taylor, MD, Principal Investigator
Center for Prospective Outcome Studies, Inc., Atlanta, Georgia 30327, United States; Recruiting
Site Contact
L.D. Empting, MD, Principal Investigator
North Georgia Premier Research, Dawnsonville, Georgia 30534, United States; Recruiting
Site Contact
William J. Keating, MD, Principal Investigator
Rehabilitation Associates of Indiana, Indianapolis, Indiana 46250, United States; Recruiting
Site Contact
Marc Duerden, MD, Principal Investigator
Tristate Arthritis & Rheumatology Center, LLC, Evansville, Indiana 47714, United States; Recruiting
Site Contact
Moges Sisay, MD, Principal Investigator
Integrated Clinical Trial Services, Inc., West Des Moines, Iowa 50265, United States; Recruiting
Site Contact
Kathleen Gannon, MD, Principal Investigator
International Clinical Research Institute, Inc., Overland Park, Kansas 66211, United States; Recruiting
Site Contact
Srinivas Nalamachu, MD, Principal Investigator
Kansas City Bone & Joint Clinic, Inc., Overland Park, Kansas 66211, United States; Recruiting
site contact
Atul T Patel, MD, Principal Investigator
Willis-Knighton Pain Management Center, Shreveport, Louisiana 71103, United States; Recruiting
Site Contact
Randall Brewer, MD, Principal Investigator
Mid Atlantic Pain Medicine Center, Pikesville, Maryland 21208, United States; Recruiting
Site Contact
Marcia Wolf, MD, Principal Investigator
The Rehabilitation Team West, Baltimore, Maryland 21228, United States; Completed
Englewood Hospital and Medical Center, Englewood, New Jersey 07631, United States; Recruiting
Site Contact
Jeffrey Gudin, MD, Principal Investigator
Lovelace Scientific Resources, Inc., Albuquerque, New Mexico 87108, United States; Recruiting
Site Contact
Craig S. Nairn, MD, Principal Investigator
Mount Sinai School of Medicine, New York, New York 10029, United States; Not yet recruiting
Site Contact
David Simpson, MD, Principal Investigator
Metropolitan Hospital Center, New York, New York 10029, United States; Not yet recruiting
Site Contact
Lauren Shaiova, MD, Principal Investigator
PharmQuest, Greensboro, North Carolina 27401, United States; Recruiting
Site Contact
Alexander Murray, MD, Principal Investigator
Raleigh Neurology Associate, Raleigh, North Carolina 27607, United States; Recruiting
Site Contact
Pavan Yerramsetty, MD, Principal Investigator
Peters Medical Research, High Point, North Carolina 27262, United States; Completed
Duke University Medical Center, Durham, North Carolina 27710, United States; Not yet recruiting
Site Contact
Amy Abernethy, MD, Principal Investigator
Columbus Clinical Research, Columbus, Ohio 43213, United States; Recruiting
Site Contact
Samir Arora, MD, Principal Investigator
Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States; Recruiting
Site Contact
Frederick Murphy, DO, Principal Investigator
University of Pennsylvania, Philadelphia, Pennsylvania 19146, United States; Recruiting
Site Contact
Michael Ashburn, MD, Principal Investigator
Comprehensive Pain Specialists, PLLC, Hendersonville, Tennessee 37075, United States; Recruiting
Site Contact
Peter Kroll, MD, Principal Investigator
Consultants in Pain Research, San Antonio, Texas 78209, United States; Recruiting
Site Contact
Donald Bacon, MD, Principal Investigator
InVisions Consultants, LLC, San Antonio, Texas 78218, United States; Completed
Northwest Clinical Research Center, Bellevue, Washington 98004, United States; Recruiting
Site Contact
Arifulla Khan, MD, Principal Investigator
The Center for Pain Relief, Charleston, West Virginia 25301, United States; Recruiting
Site Contact
Robert Bowman, MD, Principal Investigator
