Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients
Condition: Cancer Pain; Breakthrough Pain
MeSH terms: Cancer Pain; Breakthrough Pain
Intervention: Fentanyl Buccal Tablet (FBT)
Intervention description: FBTs were self-administered by participants via the oral mucosa. During the open-label dose titration period, participants used 1 to 4 tablets of the 100 mcg or 200 mcg strength to individually titrate upwards to an effective dose through the range of available strengths (i.e. 100, 200, 400, 600, or 800 mcg). For the open-label treatment and continuation periods, single dose tablets at the effective dose identified during the titration period were used. The maximum dose allowed per breakthrough pain (BTP) episode was 800 mcg. On any single day, participants were not to use FBT for more than 4 BTP episodes.
Intervention MeSH terms: Fentanyl
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 330.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breakthrough Cancer Pain

Summary:

      Breakthrough cancer pain (BTcP) is a common problem in patients with cancer. Fentanyl Buccal
      Tablet (FBT) is used for the treatment of BTP in adults with cancer who are already receiving
      maintenance opioid therapy for chronic cancer pain. FBT treatment should be individually
      titrated to an effective dose that provides adequate analgesia and minimizes undesirable
      effects. To reach the safest effective dose for the individual patient as soon as possible,
      the dose titration process is critical. The aim of this study, conducted under pragmatic
      conditions in a large-scale population of cancer patients is to compare the proportion of
      patients reaching an effective FBT dose after titration starting with either a 100 mcg dose
      or a 200 mcg dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is willing to provide written informed consent to participate in this
             study.

          -  The patient can be either an out-patient or an in-patient.

          -  The patient has a histologically documented diagnosis of cancer.

          -  The patient has stable background pain due to cancer.

          -  The patient experiences up to 4 BTcP episodes per 24 hours.

          -  As maintenance opioid therapy, the patient is currently taking 1 of the following: at
             least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at
             least 30 mg of oxycodone/day, at least 8 mg of hydromorphone/day, of an equianalgesic
             dose of another opioid for a week or longer before administration of the first dose of
             study drug.

          -  Women of childbearing potential, using a medically accepted, highly effective method
             of birth control and agree to continued use of this method for the duration of the
             study.

          -  The patient must be willing and able to successfully self-administer the study drug
             and to fill in study documents.

        Exclusion Criteria:

          -  The patient is without maintenance opioid therapy.

          -  The patient has uncontrolled or rapidly escalating pain as determined by the
             investigator.

          -  The patient has known or suspected hypersensitivities, allergies, or other
             contraindications to the active drug or to any of the excipients of the study drug.

          -  The patient has respiratory depression or chronic obstructive pulmonary disease, or
             any other medical condition predisposing to respiratory depression.

          -  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.

          -  The patient is pregnant or lactating.

          -  The patient has participated in a study involving an investigational drug in the prior
             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 could, in the opinion of the
             investigator, compromise the patient's safety or compliance with the study protocol,
             or compromise collected data.