SUBLINGUAL FENTANYL VERSUS SUBCUTANEOUS MORPHINE

INTERVENTION: Trade Name: Abstral Product Name: sublingual fentanyl Product Code: N02AB03 Pharmaceutical Form: Sublingual tablet Pharmaceutical form of the placebo: Sublingual tablet Route of administration of the placebo: Sublingual use CONDITION: pain due to cancer Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: The main aim of the study is to show non inferiority of sublingual fentanyl (SLF) with respect to subcutaneous morphine (SCMO) in the treatment of severe cancer pain episodes in the first 30 minutes after drug assumption, in cancer patients regularly treated with opioids.; Pain intensity in the first 30 minutes after drug administration, calculated as average value of pain “right now” scores at 10, 20 and 30 minutes after drug administration is the main outcome measure.; Primary end point(s): to show non inferiority of sublingual fentanyl (SLF) with respect to subcutaneous morphine (SCMO) in the treatment of severe cancer pain episodes in the first 30 minutes after drug assumption, in cancer patients regularly treated with opioids. Secondary Objective: Secondary efficacy endpoints are to compare:; a) analgesic efficacy at 60 minutes; b) proportion of patients needing a second dose of opioid; c) proportion of patients that express a preference for one administration route; d) safety and tolerability (adverse drug reactions (ADR), adverse events (AEs) and serious adverse events (SAE) occurring during the study).; e) effectiveness, safety and tolerability of SLF and SCMO in patients regularly on low dosages of opioids.; Timepoint(s) of evaluation of this end point: at 0, 10, 20, 30, 60 minutes after the beginning of the study SECONDARY OUTCOME: Secondary end point(s): effectiveness, safety and tolerability of SLF and SCMO Timepoint(s) of evaluation of this end point: after 30 and 60 minutes after the beginning of the study INCLUSION CRITERIA: ‐ active oncological disease causing pain ‐ stable opioid therapy (> 3 days) ‐ adequate pain control in the previous 24 hours (average pain in the previous 24 hours of = 4/10) ‐ episode of breakthrough pain occurring at the time of the visit (current pain = 6/10) ‐ previous 24 hours daily dosage of opioid, calculated as equianalgesic dose of oral morphine, between 20 and 120 mg/day ‐ written informed consent to study participation ‐ age = 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 42