- To confirm the efficacy of intranasal fentanyl titrated to doses 50, 100 or 200 µg for
•To explore the relationship between dose of background opioid treatment and titrated
Minimum age: 18 Years.
Maximum age: 80 Years.
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 â¥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 Âµg/hour? For conversion
6. Is the background pain generally stable and on average controlled to a mild level
(defined as â¤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 analgsics) 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
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
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
4. Has the patient severe hepatic impairment? (Investigator's judgement according to
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 Âµg/hour transdermal fentanyl
or the number of BTP episodes will be less than three per week during the trial
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
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
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?