Clinical trial NCT00362583 (phase 3, status: completed)
Conditions: cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: fentanyl
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C
Eligibility criteria:

        Inclusion Criteria:

          1. Has the patient given informed consent according to local requirements before any
             trial-related activities? Trial-related activities are any procedure that would not
             have been performed during the routine management of the patient

          2. Is the patient a cancer patient with breakthrough pain?

          3. Is the patient aged ≥18 years?

          4. Has the patient received for at least the past month either oral morphine, oxycodone,
             hydromorphone or transdermal fentanyl for treatment of background pain?

          5. Is the current dose of the scheduled background opioid of the patient equivalent to
             60-500 mg oral morphine/day or to transdermal fentanyl 25-200 µg/hour? For conversion
             table.

          6. Is the background pain generally stable and on average controlled to a mild level
             (defined as ≤4 on an 11 point NRS) by the background opioid?

          7. Is the BTP(s) in general of so severe pain intensity that the patient judges he/she
             needs additional analgesics (apart from background pain analgesics) and does it
             normally last for more than 15 minutes?

          8. Does the patient in general while using a stable, fixed-schedule, opioid regimen have
             at least three BTP episodes per week but no more than four BTP episodes per day?*

          9. Has the patient obtained at least partial relief of BTP(s) with his/her usual
             immediate-release strong opioid, i.e. oral morphine, oxycodone, hydromorphone or
             transmucosal fentanyl?

         10. Is the patient able to use intranasal drugs?

         11. Does the patient use adequate contraceptive precaution (contraceptive pill, implant or
             injection or intrauterine device) in the trial period?

         12. Did the patient have a negative pregnancy test at the inclusion in studies FT-016-IM
             or FT-017-IM?

        Exclusion Criteria:

        All exclusion criteria must be answered "no" for a patient to participate in the trial.

          1. Does the patient have a recent history of substance abuse?

          2. Is the patient pregnant or nursing during the trial period?

          3. Has the patient neurological or psychiatric impairment that may compromise data
             collection?

          4. Has the patient severe hepatic impairment? (Investigator's judgement according to
             local practice)

          5. Has the patient had any recent therapy, which could potentially alter pain or response
             to analgesics to a degree, where the need for background opioid will be less than 60
             mg morphine or morphine equivalents/day or less than 25 µg/hour transdermal fentanyl
             or the number of BTP episodes will be less than three per week during the trial
             period?

          6. Has the patient had facial radiotherapy?

          7. Has the patient been treated with MAO inhibitor within the last 14 days?

          8. Does the patient use Methadone or Buprenorphine?

          9. Does the patient have an impaired respiratory function to an extent, which may
             severely increase the risk of clinically relevant respiratory depression by BTP
             fentanyl treatment?

         10. Does the patient use drugs for intranasal administration?

         11. Does the patient have nasopharyngeal probe?

         12. Is the patient known to be hypersensitive to fentanyl or to other opioids or any of
             their excipients?

         13. Has the patient any head injury, primary brain tumour or other pathological
             conditions, which could significantly increase the risk of increased intracranial
             pressure or impaired consciousness?

         14. Has the patient concomitant participation in any other trial with an investigational
             drug or device apart from cancer treatment and participation in intranasal fentanyl
             trials FT-016-IM/ FT-017-IM within 30 days prior to inclusion in this trial?

         15. Does the patient have pathological conditions of the nasal cavity as contraindication
             to intranasal fentanyl?