Intranasal Fentanyl for the Treatment of Breakthrough Pain in Cancer Patients (FT-017-IM)

Inclusion criteria

• Has the patient given informed consent according to local requirements before any trial-related activities? Trial-related activities are any procedures that would not have been performed during the routine management of the patient.
• Is the patient a cancer patient with breakthrough pain?
• Is the patient aged ≥ 18 years?
• Has the patient received, for at least the past month, either oral morphine, oxycodone, hydromorphone, or transdermal fentanyl for treatment of background pain?
• Is the current dose of the scheduled background pain opioid of the patient equivalent to 60-500 mg oral morphine/day or to 25-200 µg/hour transdermal fentanyl?
• Is the background pain generally stable and on average controlled to a mild level (defined as ≤ 4 on an 11-point numerical rating scale [NRS]) by the background pain opioid?
• Is the BTP(s) in general of such severe pain intensity that the patient judges he/she needs additional analgesics (apart from background pain medication) and does it normally last for more than 15 minutes?
• 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?
• 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?
• Is the life expectancy of the patient at least 3 months?
• Is the patient able to use intranasal drugs?
• Does the patient use adequate contraceptive precautions (contraceptive pill, implant or injection, or intrauterine device) in the trial period?
• Does the patient have a negative pregnancy test?
• Was the background pain, during a minimum of five of the seven days, controlled to a mild level (defined as ≤ 4 on an 11-point NRS) by the background pain opioid?
• Did the patient have at least three BTP episodes during the seven days but no more than four BTP episodes per day?
• Was the BTP(s) of such severe pain intensity that the patient took additional analgesics (apart from the usual background pain opioid)?

Exclusion criteria

• Does the patient have a recent history of substance abuse?
• Is the patient pregnant or nursing during the trial period?
• Does the patient have neurological or psychiatric impairment that may compromise data collection?
• Does the patient have severe hepatic impairment? (Investigator's judgement according to local practice.)
• Has the patient had any recent therapy, which could potentially alter pain or response to analgesics to a degree, where the need for background pain 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?
• Has the patient had facial radiotherapy?
• Has the patient been treated with a monoamine oxidase (MAO) inhibitor within the last 14 days?
• Does the patient use methadone or buprenorphine?
• Does the patient have impaired respiratory function to an extent which may severely increase the risk of clinically relevant respiratory depression by BTP fentanyl treatment?
• Does the patient use drugs for intranasal administration?
• Does the patient have a nasopharyngeal probe?
• Is the patient known to be hypersensitive to fentanyl or to other opioids or any of their excipients?
• Does the patient have any head injury, primary brain tumour, or other pathological conditions which could significantly increase the risk of increased intracranial pressure or impaired consciousness?
• Is the patient concomitantly participating in any other trial with an investigational drug or device apart from cancer treatment and participation in NAF trial FT-016-IM within 30 days prior to inclusion in this trial?
• Does the patient have pathological conditions of the nasal cavity as contraindications to intranasal fentanyl?