Clinical Trials Register

Summary
EudraCT Number:	2015-000944-41
Sponsor's Protocol Code Number:	FenS-FenD
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-11-05
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-000944-41

A.3

Full title of the trial

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 .

Studio pilota per valutare la fattibilit¿ di un trial a due bracci, in doppio cieco, a gruppi paralleli, randomizzato e controllato per il confronto della durata dell¿efficacia analgesica di un cerotto di fentanil a singola matrice rispetto ad un cerotto di fentanil a doppia matrice

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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 .

Studio per valutare la fattibilit¿ di una sperimentazione a due bracci per il confronto della durata dell¿efficacia analgesica di un cerotto di fentanil a singola matrice rispetto ad un cerotto di fentanil a doppia matrice

A.3.2

Name or abbreviated title of the trial where available

FenS-FenD

A.4.1

Sponsor's protocol code number

FenS-FenD

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	nessun finanziamento
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fondazione IRCCS Istituto Nazionale dei tumori
B.5.2	Functional name of contact point	Trialcenter
B.5.3	Address:
B.5.3.1	Street Address	Via venezian 1
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20133
B.5.3.4	Country	Italy
B.5.4	Telephone number	0223903824
B.5.5	Fax number	0223903991
B.5.6	E-mail	trialcenter@istitutotumori.mi.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	FENTALGON - 25 MCG/H CEROTTI TRASDERMICI 3 CEROTTI IN BUSTINE PET/AL/PP
D.2.1.1.2	Name of the Marketing Authorisation holder	ITALFARMACO S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Fentalgon
D.3.2	Product code	039359017
D.3.4	Pharmaceutical form	Transdermal patch
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	DUROGESIC - 25 MCG/ORA CEROTTI TRASDERMICI 3 CEROTTI
D.2.1.1.2	Name of the Marketing Authorisation holder	JANSSEN CILAG S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Durogesic
D.3.2	Product code	029212053
D.3.4	Pharmaceutical form	Transdermal patch
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with oncological pain

pazienti da affetti da dolore oncologico

E.1.1.1

Medical condition in easily understood language

Patients with oncological pain

pazienti da affetti da dolore oncologico

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10033371
E.1.2	Term	Pain
E.1.2	System Organ Class	10018065 - General disorders and administration site conditions

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Valutare la fattibilit¿ di uno studio in doppio cieco che testa la superiorit¿ della formulazione di fentanil a doppia matrice (DMF) rispetto ad una formulazione a singola matrice (SMF) nel mantenimento dell'analgesia nelle ultime otto ore di posizionamento del cerotto per il trattamento del dolore cronico da cancro

E.2.2

Secondary objectives of the trial

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.

Sperimentare e valutare la fattibilit¿ dei seguenti endpoints che verranno utilizzati in un futuro studio principale:
-L'intensit¿ media del dolore delle ultime 8 ore delle previste 72 ore di durata del cerotto (misura dell¿outcome principale);
-Il consumo medio giornaliero di oppioidi PRN nelle ultime 24 ore di durata del cerotto (misura dell¿outcome principale);
-La durata della analgesia del cerotto (tempo dal posizionamento alla prima valutazione dell'intensit¿ del dolore >4 durante le 72 ore di durata del cerotto);
-Il verificarsi di eventi avversi (AE) e reazioni avverse (ADR) durante le 72 ore di trattamento

E.2.3

Trial contains a sub-study

E.3

Principal 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

-Dolore dovuto a una malattia oncologica attiva
-Età pari o superiore ai 18 anni
-Terapia stabile con Durogesic® nei precedenti 6 giorni, con necessità di sostituire il cerotto ogni 60 ore o meno
-Controllo adeguato della sintomatologia dolorosa nelle ultime 24 ore (NRS=4)
-Numero di somministrazione di farmaci analgesici per il trattamento del breakthrough pain = 3
-KPS = 50
-Consenso informato scritto

E.4

Principal 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

-Pazienti che utilizzano cerotti di fentanyl da 12,5 mcg/h
-Radioterapia e/o chemioterapia entro i 15 giorni precedenti l’arruolamento
-Deficit cognitivi che compromettono la capacità di valutare il dolore e il sollievo del dolore
-Gravidanza o allattamento
-Severa insufficienza epatica e/o renale
-Partecipazione ad altri progetti di ricerca che sono in conflitto o potrebbero confondere i risultati dello studio

E.5 End points

E.5.1

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

Valutare la fattibilità di uno studio in doppio cieco che testa la superiorità della formulazione di fentanil a doppia matrice (DMF) rispetto ad una formulazione a singola matrice (SMF) nel mantenimento dell'analgesia nelle ultime otto ore di posizionamento del cerotto per il trattamento del dolore cronico da cancro.
I principali endpoints di fattibilità dello studio pilota sono:
-La velocità di reclutamento;
-La percentuale di pazienti arruolati con successo, su tutti quelli potenzialmente eleggibili;
-La percentuale di pazienti con un follow-up completo mantenendo la cecità, rispetto a quelli arruolati;
-Le ragioni del non arruolamento di pazienti potenzialmente eleggibili;
-Le ragioni di un follow-up incompleto o di un non mantenimento della cecità.

E.5.1.1

Timepoint(s) of evaluation of this end point

72 hrs

72 ore

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

72 hrs

72 ore

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-11-05.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

routine clinical follow up

normale follow up clinico

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-04-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-03-26

P. End of Trial
P.	End of Trial Status	Ongoing

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