Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for Breakthrough Pain in Patients With Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain; Breakthrough Pain
Intervention: Fentanyl Buccal Tablet; Immediate release oxycodone
Intervention description: FBT dose strengths = 200, 400, 600, or 800 mcg (1, 2, 3, or 4 tablets) taken prn (as needed) in the event of breakthrough pain.
The maximum dose of FBT permitted during the titration and double-blind periods in this study is 800 mcg (4 tablets).
For the subsequent 12-week open-label treatment period, patients will either continue with FBT treatment or begin treatment with an alternative short-acting opioid deemed appropriate for each patient by the clinician.; Immediate release oxycodone dosage strength: 15, 30, 45, and 60 mg doses (1, 2, 3 or 4 capsules) to be taken prn (as needed) for breakthrough pain.
The maximum single dose would be 60 mg (4 capsules).
Intervention MeSH terms: Fentanyl; Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 213.0
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 the fentanyl buccal tablet (FBT) compared with
      immediate release oxycodone treatment in alleviating breakthrough pain (BTP) in opioid
      tolerant patients with chronic pain.
    

Eligibility criteria:

        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 FBT or oral transmucosal fentanyl citrate for BTP.

          -  The patient is currently using 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.