Clinical Trials Register

Summary
EudraCT Number:	2012-005357-23
Sponsor's Protocol Code Number:	01
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:	2013-01-11
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

2012-005357-23

A.3

Full title of the trial

Preventing injection pain by Clostridium Histolyticum Collagenase Administration for teatment of Dupuytrens contracture

Prevenzione del dolore con uso diInjection anestetico locale EMLA nella infiltrazione con Collagenasi

A.3.1

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

The purpuse of this study is , in subjets affected by Dupuytren's and treated with local injection of Xiapex into fibrotic Dupuytren's cords , to promote patient confort and satisfaction by relieve pain due to Xiapex injection by the use of EMLA cream

Lo studio deve validare l'efficacia dell'uso di un anestetico locale ( EMLA ) , per prevenire il dolore quando si effettua infiltrazioni locali con Collagenasi ( Clostridium Histolyticum Collagenase ).

A.3.2

Name or abbreviated title of the trial where available

relieve pain for dupuitren cord by EMLA

prevenz, dolore utilizzando an. loc. nel Dupuytren

A.4.1

Sponsor's protocol code number

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	AUSL VITERBO
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Pfizer
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	AUSL Viterbo
B.5.2	Functional name of contact point	UOC Chirurgia della Mano
B.5.3	Address:
B.5.3.1	Street Address	Via E. Fermi, 15
B.5.3.2	Town/ city	Viterbo
B.5.3.3	Post code	01100
B.5.3.4	Country	Italy
B.5.4	Telephone number	335-6776764
B.5.5	Fax number	0761-339375
B.5.6	E-mail	antonio.castagnaro@alice.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	No
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	Xiapex
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	Xiapex
D.3.9.4	EV Substance Code	collagenasi
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	.58
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	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	EMLA*CR 5TUB 5G 2,5+2,5%+10CER
D.2.1.1.2	Name of the Marketing Authorisation holder	ASTRAZENECA SpA
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.3.4	Pharmaceutical form	Cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	lidocaina, prilocaina
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.5
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

Dupuytren s Disease

Malattia di Dupuytren

E.1.1.1

Medical condition in easily understood language

Dupuytren s Disease

Malattia di Dupuytren

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	SOC
E.1.2	Classification code	10028395
E.1.2	Term	Musculoskeletal and connective tissue disorders
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess pain (due to the needle) immediately after Xiapex injection;

Valutare il dolore (dovuto all ago) immediatamente dopo l iniezione di Xiapex

E.2.2

Secondary objectives of the trial

To assess pain (due to drug) immediately after Xiapex injection; ;
Investigator assessment on degree of difficulty with Xiapex injection; ;
To evaluate Patient Global Treatment Satisfaction (at discharge); ;
To evaluate global pain at the discharge and after 24h from Xiapex injection ;
(before breaking the cords).

Valutare il dolore (dovuto al farmaco) immediatamente dopo l iniezione di Xiapex; Valutazione dello sperimentatore del grado di difficolta con iniezione di Xiapex; Valutare il grado di soddisfazione complessiva del paziente (alla dimissione);Valutare il dolore complessivo alla dimissione e dopo 24h dall iniezione di Xiapex(prima della rottura delle corde).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

At least 18 years of age and 75 years. ;
Patient naive to Xiapex injection. ;
Presenting with a Dupuytren s contracture of at least 20 degr caused by a palpable ;
cord in at least one finger other than the thumb. ;
In good health, based upon the results of a medical history, physical examination, ;
and safety laboratory profile. ;
Female subjects of child bearing potential must use a highly effective ;
contraception method or be surgically sterilized or be a post menopausal female ;
(i.e., no menses for at least 1 year). A pregnancy test could be performed prior to ;
enrollment in the study. ;
Evidence of a personally signed and dated informed consent document indicating ;
that the subject (or a legally acceptable representative) has been informed of all ;
pertinent aspects of the study. ;
Subjects who are willing and able to comply with scheduled visits, treatment plan, ;
laboratory tests, and other study procedures.

Il paziente con un eta compresa tra i 18 ed i 75 anni; ;
Il paziente mai stato sottoposto ad un trattamento con lo Xiapex; ;
Presenza di una contrattura di Dupuytren di almeno 20 gradi causata da una corda ;
fibrosa palpabile in almeno una delle dita; ;
Paziente in buona salute, sulla base dei risultati dell anamnesi, dell esame obiettivo ;
e dalle analisi di laboratorio; ;
Le donne in età fertile devono utilizzare metodi contraccettivi altamente efficaci o ;
essere state sterilizzate chirurgicamente o essere in menopausa (ad esempio, ;
nessun ciclo mestruale da almeno un anno). Un test di gravidanza potrebbe essere ;
effettuato prima dell ingresso nello studio. ;
Presenza di un consenso informato firmato e datato dal soggetto (o da un suo ;
legale rappresentante) che illustri gli aspetti pertinenti allo studio. ;
Soggetti che sono disposti e sono in grado di rispettare le visite programmate, il ;
piano di trattamento e tutte le altre procedure richieste dallo studio.

E.4

Principal exclusion criteria

Patients who have known anaphylactic hypersensitivity to the anaesthetics of the ;
amide type or any of the components of EMLA cream. ;
Patients who are pregnant or breast feeding. ;
Patient with glucose-6-phosphate dehydrogenase deficiency or congenital/ ;
acquired methaemoglobinaemia. ;
Patient with open wounds, infections, atopic dermatitis, skin rashes or cuts at, or ;
near, the area where it is needed to apply EMLA Cream. ;
Patients with a chronic pain diagnosis. ;
Patient with severe kidney or liver disease. ;
On an investigational drug within 30 days prior to the first dose of study drug. ;
Received a treatment on the selected joint, within 90 days of enrolment in the ;
study, for Dupuytren s contracture including needle aponeurotomy or any surgical ;
procedure. ;
Patients with a known systemic hypersensitivity to collagenase or any of the other ;
product excipients. ;
On anticoagulant medication or has received anticoagulant medication (except ;
aspirin less than 150 mg daily) within 7 days before the first injection. ;
Has any clinically significant medical history or condition(s), including conditions ;
that affect the hands, that would, in the opinion of the investigator, substantially ;
increase the risk associated with the subject s participation in the protocol or ;
compromise the scientific objectives of the study. ;
Has a chronic muscular, neurological, or neuromuscular disorder that affects the ;
hands. ;
Other severe acute or chronic medical or psychiatric condition or laboratory ;
abnormality that may increase the risk associated with study participation or ;
investigational product administration or may interfere with the interpretation of ;
study results and, in the judgement of the investigator, would make the subject ;
inappropriate for entry into this study. ;
Has jewellery on the hand to be treated that cannot be removed.

Pazienti che presentano ipersensibilita al principio attivo o ad uno qualsiasi degli ;
eccipienti che compongono l EMLA. ;
Donne in gravidanza o in allattamento. ;
Pazienti con insufficiente glucosio-6-fosfato deidrogenasi o con metaemoglobinemia ;
congenita o idiopatica. ;
Pazienti con ferite aperte, infezioni, dermatite atopica, irritazioni della pelle o tagli in ;
prossimita o sull area stessa in cui deve essere applicato lo strato di EMLA in ;
crema. ;
Pazienti con diagnosi di dolore cronico. ;
Pazienti con grave insufficienza renale o disfunzioni al fegato. ;
Partecipazione ad un altro studio a norme GCP nei 30 giorni precedenti la ;
somministrazione del farmaco. ;
Pazienti che abbiano ricevuto un trattamento sull articolazione selezionata, nei 90 ;
giorni di arruolamento nello studio, per la contrattura di Dupuytren incluso ;
l aponeuretomia e l intervento chirurgico. ;
Pazienti con ipersensibilita conosciuta al collagenase o a qualunque dei suoi ;
eccipienti. ;
Pazienti in trattamento con anticoagulanti o che hanno ricevuto un trattamento con ;
anticoagulanti (ad eccezione dell aspirina con un dosaggio di meno di 150 mg al ;
giorno) nei 7 giorni precedenti alla prima iniezione. ;
Pazienti che presentano delle condizioni cliniche che interessano le mani tali da, ;
secondo dello sperimentatore, aumentare in maniera sostanziale il rischio associato ;
alla partecipazione del soggetto al protocollo o compromettere gli obiettivi scientifici ;
dello studio. ;
Pazienti che presentano disturbi muscolari cronici, neurologici o neuromuscolari che ;
interessano le mani. ;
Altre condizioni mediche o psichiatriche gravi, acute o croniche, o anomalie di ;
laboratorio che potrebbero aumentare il rischio legato alla partecipazione del ;
paziente allo studio o alla somministrazione del farmaco investigato o potrebbero ;
interferire con l interpretazione dei risultati e, sulla base del giudizio dello ;
sperimentatore, potrebbero rendere il soggetto inadeguato all ingresso nello studio. ;
Pazienti con gioielli che non possono essere rimossi dalle mani da trattare.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is pain due to Xiapex injection (needle insertion) assessed by ;
means of VAS.

dolore dovuto all iniezione di Xiapex (inserimento dell ago) ;
valutato tramite i valori medi della VAS

E.5.1.1

Timepoint(s) of evaluation of this end point

6 months form study treatment

6 mesi dal trattamento

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

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

Yes

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

12 pt con EMLA e 12 senza

12 pts with EMLA and 12 without

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.8.6 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

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

As defined in protcol

come definita nel protocollo

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

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

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.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)

not applicable

non applicabile

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

2013-01-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-01-24

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

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