comparison between sublingual fentanyl and subcutaneous morphine in patients with sever episode of cancer pain

SUBLINGUAL FENTANYL VERSUS SUBCUTANEOUS MORPHINE FOR THE MANAGEMENT OF SEVERE CANCER PAIN EPISODES IN PATIENTS ON OPIOID TREATMENT: A DOUBLE-BLIND RANDOMIZED NON–INFERIORITY TRIAL.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003319-23-IT

Enrollment

112

Registered

2013-10-23

Start date

2013-11-07

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pain due to cancer

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: cognitive deficits compromising the ability to assess pain or pain relief - previous therapy with sublingual fentanyl -pregnancy or breastfeeding - severe hepatic and/or renal impairment - participation in other clinical trial that might interfere with the study results

Design outcomes

Primary

Measure	Time frame
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. ;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. ;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.;Timepoint(s) of evaluation of this end point: at 0, 10, 20, 30, 60 minutes after the beginning of the study	—

Measure

Time frame

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. ;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. ;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.;Timepoint(s) of evaluation of this end point: at 0, 10, 20, 30, 60 minutes after the beginning of the study

—

Secondary

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactCaraceni

Fondazione IRCCS Istituto Nazionale dei Tumori

+390223902792

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026