Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain; Breakthrough Pain
Intervention: Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone
Intervention description: 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, followed by 2 double-blind crossover treatment periods (in randomized order). For the double-blind treatment period of the study involving FBT administration, a patient is randomly assigned to receive FBT at the 200, 400, 600, or 800 mcg strength found to be successful during open-label titration. For the double-blind treatment period of the study to which a patient is randomly assigned to receive immediate-release oxycodone, the patient will receive immediate-release oxycodone at the strength (15, 30, 45, or 60 mg) found to be successful during open-label titration.
Intervention MeSH terms: Fentanyl; Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 323.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Breakthrough pain; Opioid-tolerant; Chronic pain

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.
    

Eligibility 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.