Evaluate the efficacy of treatment with the fentanyl buccal tablet (FBT) compared with
immediate release oxycodone treatment in alleviating breakthrough pain (BTP) in opioid
tolerant patients with chronic pain.
Key Inclusion Criteria:
- The patient has chronic pain of at least 3 months duration associated with any of the
following conditions: diabetic peripheral neuropathy, postherpetic neuralgia,
traumatic injury, complex regional pain syndrome, back pain, neck pain, fibromyalgia,
chronic pancreatitis, osteoarthritis, rheumatoid arthritis, or cancer. Other chronic
painful conditions may be evaluated for possible inclusion.
- The patient is currently using at least one 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, including a written opioid
agreement form, to participate in this study.
- 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 24 hours prior to screening, 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, at least 1 and less than 5 BTP episodes per day
while taking ATC opioid therapy, and on average, the duration of each BTP episode is
less than 4 hours during the screening period.
- 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.
Key Exclusion Criteria:
- The patient has uncontrolled or rapidly escalating pain as determined by the
investigator 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 a diagnosis of chronic headache or migraine as the primary painful
condition with associated BTP.
- 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 the patient's safety or collected data.
- The patient has suicidal ideation at screening or has a history of suicidal ideation
within 1 year or history of suicide attempt within 2 years before screening, or a
diagnosis of bipolar disorder or history of schizophrenia
- 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 (e. g., 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 (i. e., active metabolites).
- The investigator feels that the patient is not suitable for the study for any reason
(e. g., the patient's social history indicates an increased risk of drug diversion)
- Additional exclusion criteria will apply for patients who decide to participate in the
pharmacokinetics assessment to be performed at designated study sites.
Pacific Coast Pain Management, Laguna Hills, California 92637, United States; Recruiting
Site Contact
Gold Coast Research, Plantation, Florida 33324, United States; Recruiting
Site Contact
Sarasota Pain Medicine Research, Sarasota, Florida 34238, United States; Recruiting
Site Contact
Clinical Research of West Florida, Tampa, Florida 33603, United States; Recruiting
Site Contact
Millennium Pain Center, Bloomington, Illinois 61701, United States; Recruiting
Site Contact
ICRI Inc., Overland Park, Kansas 66211, United States; Recruiting
Site Contact
The Pain Treatment Center of the Bluegrass, Lexington, Kentucky 40503, United States; Recruiting
Site Contact
Columbia Medical Practice, Columbia, Maryland 21045, United States; Recruiting
Site Contact
Clinical Research Center, West Reading, Pennsylvania 19611, United States; Recruiting
Site Contact
CRI Worldwide, Philadelphia, Pennsylvania 19139, United States; Recruiting
Site Contact
Aspen Clinical Research, Orem, Utah 84058, United States; Recruiting
Site Contact
