A STUDY TO TEST THE FEASIBILITY OF A TWO-ARM, TRIAL FOR THE COMPARISON OF THE DURATION OF THE ANALGESIC EFFICACY OF A SINGLE MATRIX TRANSDERMAL FENTANYL PATCH COMPARED VS A DOUBLE MATRIX TRANSDERMAL FENTANYL PATCH .

A PILOT STUDY TO TEST THE FEASIBILITY OF A TWO-ARM, DOUBLE BLIND, PARALLEL-GROUP, RANDOMIZED CONTROLLED TRIAL FOR THE COMPARISON OF THE DURATION OF THE ANALGESIC EFFICACY OF A SINGLE MATRIX TRANSDERMAL FENTANYL PATCH COMPARED VS A DOUBLE MATRIX TRANSDERMAL FENTANYL PATCH . - FenS-FenD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000944-41-IT

Enrollment

Registered

2020-11-05

Start date

2015-04-20

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Patients with oncological pain MedDRA version: 20.0 Level: PT Classification code 10033371 Term: Pain System Organ Class: 10018065 - General disorders and administration site conditions

Interventions

Trade Name: FENTALGON - 25 MCG/H CEROTTI TRASDERMICI 3 CEROTTI IN BUSTINE PET/AL/PP Product Name: Fentalgon Product Code: 039359017 Pharmaceutical Form: Transdermal patch Trade Name: DUROGESIC - 2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Pain due to active oncological disease • Age = 18 years • Pain treatment with stable dosage of Durogesic® in the previous six days, in need of substituting the patch at or before 60 hours of treatment. • Pain controlled (average pain intensity in the previous 24 hours = 4/10) • rescue medications for the treatment of breakthrough pain for a maximum of three daily KPS = 50 • Written informed consent to study participation 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: • Patients using 12,5 mcg/h patch size • Radiation therapy and/or chemotherapy within 15 days prior to enrollment • Cognitive deficits compromising the ability to assess pain or pain relief • Pregnancy or breastfeeding • Severe hepatic and/or renal impairment • Participation in other clinical trials that might interfere with the study results

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary aim is to test the feasibility of a randomized double blind study demonstrating the superiority of DMF formulation with respect to a SMF formulation in maintaining analgesia in the last eight hours of placement of the patch for the treatment of chronic cancer pain.;Secondary Objective: To pilot and assess the feasibility of the following endpoints, that will be used in the subsequent main study: ¿The average pain intensity of the last 8 hours of the scheduled 72 hours of duration of the patch (main outcome measure) using NRS ¿The average daily consumption of PRN opioids in the last 8 hours of duration of the patch (main outcome measure) . ¿The duration of analgesia of the patch (pain free survival, i.e. time from placement to first pain intensity assessment >4 during the 72 hs of patch duration) ¿The average pain intensity during the 72 hours of treatment. ¿The average daily consumption of PRN opioids during the 72 hours of treatment . ¿Occurrence of Adverse events (AE) and Adverse drug reaction (ADR) during the 72 hours of treatment. ;Primary end point(s): The primary aim is to test the feasibility of a randomized double blind study demonstrating the superiority of DMF formulation with respect to a SMF formulation in maintaining analgesia in the last eight hours of placement of the patch for the treatment of chronic cancer pain. The main feasibility endpoints of the pilot study are: •the speed of recruitment . •percentage of successfully enrolled patients, over all the potentially eligible ones. •the percentage of patients with complete follow-up with blindness fulfillment, over enrolled ones. •the reasons of non enrollment of potentially eligible patients. •the reasons of incomplete follow-up or of blindness unfulfillment. •the percentage of patients changing the patch before the prescribed 72h duration, among potentially eligible ones ;Timepoint(s) of evaluation of this end point: 72 hrs	—

Measure

Time frame

Main Objective: The primary aim is to test the feasibility of a randomized double blind study demonstrating the superiority of DMF formulation with respect to a SMF formulation in maintaining analgesia in the last eight hours of placement of the patch for the treatment of chronic cancer pain.;Secondary Objective: To pilot and assess the feasibility of the following endpoints, that will be used in the subsequent main study: ¿The average pain intensity of the last 8 hours of the scheduled 72 hours of duration of the patch (main outcome measure) using NRS ¿The average daily consumption of PRN opioids in the last 8 hours of duration of the patch (main outcome measure) . ¿The duration of analgesia of the patch (pain free survival, i.e. time from placement to first pain intensity assessment >4 during the 72 hs of patch duration) ¿The average pain intensity during the 72 hours of treatment. ¿The average daily consumption of PRN opioids during the 72 hours of treatment . ¿Occurrence of Adverse events (AE) and Adverse drug reaction (ADR) during the 72 hours of treatment. ;Primary end point(s): The primary aim is to test the feasibility of a randomized double blind study demonstrating the superiority of DMF formulation with respect to a SMF formulation in maintaining analgesia in the last eight hours of placement of the patch for the treatment of chronic cancer pain. The main feasibility endpoints of the pilot study are: •the speed of recruitment . •percentage of successfully enrolled patients, over all the potentially eligible ones. •the percentage of patients with complete follow-up with blindness fulfillment, over enrolled ones. •the reasons of non enrollment of potentially eligible patients. •the reasons of incomplete follow-up or of blindness unfulfillment. •the percentage of patients changing the patch before the prescribed 72h duration, among potentially eligible ones ;Timepoint(s) of evaluation of this end point: 72 hrs

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Secondary

Measure	Time frame
Secondary end point(s): To pilot and assess the feasibility of the following endpoints, that will be used in the subsequent main study: ¿ The average pain intensity of the last 8 hours of the scheduled 72 hours of duration of the patch (main outcome measure) using NRS ¿ The average daily consumption of PRN opioids in the last 8 hours of duration of the patch (main outcome measure) . ¿ The duration of analgesia of the patch (pain free survival, i.e. time from placement to first pain intensity assessment >4 during the 72 hs of patch duration) ¿ The average pain intensity during the 72 hours of treatment. ¿ The average daily consumption of PRN opioids during the 72 hours of treatment . ¿ Occurrence of Adverse events (AE) and Adverse drug reaction (ADR) during the 72 hours of treatment. ;Timepoint(s) of evaluation of this end point: 72 hrs	—

Measure

Time frame

Secondary end point(s): To pilot and assess the feasibility of the following endpoints, that will be used in the subsequent main study: ¿ The average pain intensity of the last 8 hours of the scheduled 72 hours of duration of the patch (main outcome measure) using NRS ¿ The average daily consumption of PRN opioids in the last 8 hours of duration of the patch (main outcome measure) . ¿ The duration of analgesia of the patch (pain free survival, i.e. time from placement to first pain intensity assessment >4 during the 72 hs of patch duration) ¿ The average pain intensity during the 72 hours of treatment. ¿ The average daily consumption of PRN opioids during the 72 hours of treatment . ¿ Occurrence of Adverse events (AE) and Adverse drug reaction (ADR) during the 72 hours of treatment. ;Timepoint(s) of evaluation of this end point: 72 hrs

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Countries

Italy

Contacts

Public ContactTrialcenter

Fondazione IRCCS Istituto Nazionale dei tumori

trialcenter@istitutotumori.mi.it0223903824

Outcome results

None listed

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