A Clinical Trial With Intranasal Fentanyl in Cancer Patients With Breakthrough Pain
Condition: Break Through Pain; Cancer
MeSH terms: Breakthrough Pain
Intervention: Intranasal Fentanyl Spray (INFS); Placebo
Intervention description: Applied as 1 puff (= 1 dose) in one nostril, or applied as two puffs (= 2 doses, 1 in each nostril) with ten minutes apart.; Matching intranasal placebo spray
Intervention MeSH terms: Fentanyl
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Break through pain; BTP; Cancer; Intranasal Fentanyl Spray; INFS; cancer patients

Summary:

      The aim of this clinical trial was to demonstrate the efficacy of a 400 μg dose strength of
      intranasal fentanyl spray (INFS, Instanyl®) and to evaluate the safety and to establish long
      term tolerability of treatment with INFS doses of 50, 100, 200 and 400 μg.
    

Eligibility criteria:

        Inclusion Criteria:

        All inclusion criteria were answered 'yes' for a patient to participate in the clinical
        trial.

          -  Is the patient a cancer patient with breakthrough Pain (BTP)?

          -  Has the patient received either oral opioids or transdermal fentanyl for treatment of
             background pain (BGP) within the last month prior to the screening visit?

          -  Is the current dose of prescribed opioids (for BGP) equivalent to 60-1000 mg oral
             morphine/day?

          -  Has the patient's BGP for the last 7 days prior to the screening visit been generally
             stable, and on average controlled to a mild level (defined as ≤ 4 on the 11-point
             Numerical Rating Scale [NRS])?

          -  Does the patient (at the time of the screening visit) experience his/her current BTP
             episodes to be of such severe pain intensity, that he/she in general needs additional
             analgesia (i.e. on top of the background opioid treatment)?

          -  Has the patient on average for the last 7 days prior to the screening visit had at
             least three BTP episodes per week, but no more than four BTP episodes per day?

          -  Is the patient able to use intranasal drugs?

          -  Is the life expectancy of the patient at least 3 months from the date of the screening
             visit?

        Exclusion Criteria:

          1. Has the patient had an illicit substance abuse within the last year prior to
             screening?

          2. Does the patient have severe hepatic impairment? - defined as alanine aminotransferase
             (ALT or) aspartate aminotransferase (AST) levels > 3x upper limit of normal (ULN)

          3. Does the patient have severe renal impairment? - defined as serum creatinine ≥ 3.0
             mg/dl (265 micromol/L)

          4. Has the patient ever had facial radiotherapy or is the patient scheduled to facial
             radiotherapy?

          5. Has the patient been treated with any monoamine oxidase (MAO) inhibitors within the
             last 14 days prior to the screening visit?

          6. Does the patient have severe impaired respiratory function, which may increase the
             risk of clinically relevant respiratory depression by BTP fentanyl treatment?

          7. Is the patient known to be hypersensitive to fentanyl or to other opioids or any of
             their excipients?

          8. Does the patient have any head injury, primary brain tumor or other pathological
             conditions, which could significantly increase the risk of increased intracranial
             pressure or impaired consciousness?