Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain
Condition: Pain; Chronic Pain; Breakthrough Pain
MeSH terms: Chronic Pain; Breakthrough Pain
Intervention: Fentanyl Buccal Tablets
Intervention description: Fentanyl buccal tablets (FBT) placed in the buccal cavity above a rear molar until disintegrated, approximately 14-25 minutes.
Dose titration: Participants self-administered FBT, starting at 100, 200 or 400 mcg (depending on analgesic used pre-study) and titrated to 600 and 800 mcg as needed. For each breakthrough pain (BTP) episode, participants took a dose, and did not take further study drug if adequate pain relief was achieved. If pain was not controlled within 30 minutes, the same dose level was repeated. If pain relief was inadequate 30 minutes after the second dose, usual rescue medication was taken for that BTP episode. Doses were adjusted until pain relief was adequate and side effects were tolerated.
Open-label: Once the successful dose of FBT was identified (100, 200, 400, 600, or 800 mcg), participants were dispensed a 4-week supply at the successful dose. Participants were not to use FBT for more than 6 BTP episodes or take more than 8 FBT daily.
Intervention MeSH terms: Fentanyl
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The primary purpose of the study is to evaluate the impact of treatment with fentanyl buccal
      tablets on the anxiety symptoms commonly associated with chronic pain in patients with
      breakthrough pain (BTP). Other purposes are to assess the management of BTP, to evaluate
      patient functioning, and to determine any influences on the successful dose achieved.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 (i.e., barrier method
             with spermicide, steroidal contraceptive [oral, transdermal, implanted, and injected
             contraceptives must be used in conjunction with the barrier method], or intrauterine
             device [IUD]) and agree to continued use of this method for the duration of the study.

          -  The patient has chronic pain of at least 3 months duration associated with any of the
             following conditions: cancer, diabetic peripheral neuropathy, postherpetic neuralgia,
             traumatic injury, complex regional pain syndrome, back pain, neck pain, fibromyalgia
             (patient has met diagnostic criteria), chronic pancreatitis, or osteoarthritis. Other
             chronic painful conditions may be evaluated for entry upon discussion with and written
             approval from the Cephalon medical expert.

          -  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 a stable dose of around-the-clock (ATC) therapy for at least 7
             days prior to enrollment in the study.

          -  The patient reports an average pain intensity score, over the prior 24 hours, of 6 or
             less (0=no pain through 10=worst pain) for the chronic pain.

          -  The patient experiences, on average, 1 to 4 BTP episodes per day while taking
             around-the-clock (ATC) opioid therapy, and on average, the duration of each
             breakthrough pain (BTP) episode is less than 3 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, and return to the clinic for scheduled study visits
             and a follow-up evaluation 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 known or suspected hypersensitivities, allergies, or other
             contraindications to any ingredient in the study drug.

          -  The patient has a recent history (within 5 years) or current evidence of alcohol or
             other substance abuse.

          -  The patient has cardiopulmonary disease that, in the opinion of the investigator,
             would 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's primary painful condition is headache, including migraine.

          -  The patient is expected to have surgery during the study, and it is anticipated that
             the surgery will alleviate the patient's pain.

          -  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 fentanyl buccal tablets.

          -  The patient has participated in a study involving an investigational drug in the
             previous 30 days.

          -  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, in the opinion of the
             investigator, would 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 chronic pain currently being
             treated.

          -  The patient has a positive urine drug screen (UDS) for an illicit substance or a
             medication not legitimately prescribed to the patient.