Clinical Trials Register

Summary
EudraCT Number:	2005-003662-41
Sponsor's Protocol Code Number:	MW2004-11-02
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2008-10-20
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

2005-003662-41

A.3

Full title of the trial

Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care

Sbrigliamento enzimatico nei pazienti ustionati (adulti e minori): Confronto con il trattamento standard

A.4.1

Sponsor's protocol code number

MW2004-11-02

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	MEDIWOUND
B.1.3.4	Country	Israel
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	Yes
D.2.5.1	Orphan drug designation number	EU/3/02/107
D.3 Description of the IMP
D.3.1	Product name	Debrase Gel Dressing
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Gel
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.3.8	INN - Proposed INN	Debrase Gel Dressing
D.3.9.1	CAS number	37189-34-7
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.3	Concentration number	2
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	Yes
D.3.11.13.1	Other medicinal product type	mistura di enzimi proteolitici liofilizzati derivati dal fusto dell'ananas

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

Adult and children patients with burn wounds defined as deep partial thickness or full thickness thermal burns requiring hospitalization.

Pazienti adulti e minori con ustioni termiche a spessore profondo parziale o completo che richiedono ospedalizzazione.

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

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	10022117
E.1.2	Term	Injury, poisoning and procedural complications
E.1.2	System Organ Class	10022117 - Injury, poisoning and procedural complications

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The objective of this study is to evaluate the safety and enzymatic debridement efficacy of Debrase Gel Dressing (DGD)in hospitalized patients with deep partial thickness and full thickness thermal burns of 5-30% TBSA, but with total burn wounds of no more than 30% TBSA and to compare DGD to standard of care (SOC).

Obiettivo di questo studio e' valutare la sicurezza e l'efficacia di sbrigliamento enzimatico del Debrase Gel Dressing (DGD) in pazienti ospedalizzati con ustioni termiche a spessore profondo parziale o completo su 5-30% della superficie corporea totale (TBSA), ma con una estensione complessiva delle ustioni non superiore al 30% della TBSA e confrontare il DGD al trattamento standard (SOC).

E.2.2

Secondary objectives of the trial

not specified

non specificati

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Males and females between 4 years to 55 years of age, 2. Thermal burns caused by fire/flame, scalds or contact, 3. Deep partial thickness (mixed deep dermal) and/or full thickness (3°) burn wounds ≥ 5% and ≤ 30% Total Body Surface Area (TBSA); all these wounds must receive study treatment, 4. At least one wound of ≥ 2% TBSA deep partial thickness and/or full thickness burn, 5. At least 50% of the deep partial thickness and/or full thickness burn wound area of the patient is intended for surgical debridement as judged at hospital admission, 6. Total burn wounds ≤ 30% TBSA, 7. Hospital admission within 24 hours of the burn injury. Patients transferred from another hospital/clinic may be enrolled if the primary admission was within 24 hours of the burn injury and admission to the burn unit participating in the study was within 48 hours of the burn injury, 8. Signed written informed consent.

1. Maschi e femmine con un'eta' compresa tra i 4 ed i 55 anni 2. Ustioni termiche causate da fuoco/fiamme, liquidi caldi/vapore o contatto 3. Ustioni termiche a spessore profondo parziale (dermiche miste profonde) e/o a spessore completo (3°) su una superficie 5% e  30% della superficie corporea totale (TBSA); tutte queste ustioni devono ricevere il trattamento in studio 4. Almeno una ustione a spessore profondo parziale e/o a spessore completo con estensione  2% della TBSA 5. Almeno il 50% dell'area dell'ustione a spessore profondo parziale e/o a spessore completo del paziente candidata allo sbrigliamento chirurgico al momento del ricovero 6. Ustioni termiche su una area complessiva  al 30% della TBSA 7. Ricovero ospedaliero entro 24 ore dal momento in cui si e' verificata l'ustione. I pazienti trasferiti da un altro ospedale/clinica possono essere arruolati se il primo ricovero si e' verificato entro le 24 ore dall'insorgenza dell'ustione e l'ammissione al centro ustioni che partecipa allo studio si verifica entro 48 ore dall'insorgenza dell'ustione. 8. Firma del consenso informato scritto.

E.4

Principal exclusion criteria

1. Other severe cutaneous trauma at the same sites as the burns (i.e. blunt, avulsion or deep abrasion) or previous burn(s) at the same treatment site(s) or one or more burn wounds that do not meet study criteria, 2. Deep partial thickness and/or full thickness facial burn wounds, > 0.5% TBSA; study treatment of facial burns is not allowed, 3. Study treatment of perineal and/or genital burns (A patient with these wounds may be anrolled but the wounds may not be deisgnated as target wounds), 4. Circumferential anterior/posterior trunk full thickness fire/flame burns, > 15% TBSA, (Circumferential is defined as encircling ≥ 80% of the trunk circumference.) 5. A. The following pre-enrollment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3), B. Pre-enrollment wounds which are covered by eschar heavily saturated with iodine or by pseudoeschar (e.g. pseudoeschar as a result of SSD treatment), 6. Pre-enrollment escharotomy, 7. Heavily contaminated burns or pre-existing infections (Adults: WBC ≥ 20.0 x 103 cells/µL; Children aged 4-16: WBC ≥ 25.0 x 103 cells/µL), 8. Signs that may indicate smoke inhalation, 9. General condition of patient would contraindicate surgery, 10. Prisoners, 11. Pregnant women (positive pregnancy test) or nursing mothers, 12. Poorly controlled diabetes mellitus (HbA1c>9%), 13. Cardio-pulmonary disease (MI within 4 weeks prior to injury, pulmonary hypertension, COPD or pre-existing oxygen-dependent pulmonary diseases), 14. Pre-existing diseases which interfere with circulation (PVD, edema, lymphedema, surgery to the regional lymph nodes, obesity, varicose veins), 15. Immediate life threatening conditions (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, cardiovascular, liver or neoplastic disease), 16. Chronic systemic steroid intake, 17. History of allergy and/or known sensitivity to pineapples or papain, 18. Current suicide attempts, 19. Participation in another investigational drug trial, 20. Current alcohol or drug abuse. 21. Analgesic intake which prevents the patient from understanding the objectives, nature and course of the study.

1. Presenza di altri gravi traumi cutanei nello stesso sito dell'ustione (ovvero traumi da oggetti smussati, avulsione o abrasione profonda) o precedente/i ustione/i nello/negli stesso/i sito/i che richiede/richiedono il trattamento o una o piu` ustioni termiche che non rispondono ai criteri di studio 2. Ustioni al viso a spessore parziale profondo e/o a spessore completo > 0.5% TBSA; il trattamento di studio delle ustioni al viso non e` permesso 3. Trattamento di studio di ustioni perineali e/o genitali (Un paziente con queste ustioni puo` essere arruolato, ma tali ustioni non possono essere considerate come ustioni target) 4. Ustioni circumferenziali da fuoco/fiamma antero/posteriori del busto a completo spessore > 15% TBSA (Circumferenziale significa che abbraccia  80% della circonferenza del busto) 5. A. Medicazione pre arruolamento come riportato: a. Flammacerium, b. Nitrato d'Argento (AgNO3) B. Ustioni che, in fase di pre arruolamento, sono state coperte da escara pesantemente saturata di iodio o da pseudo-escara (es. pseudo-escara risultante da un trattamento con sulfadiazina d'argento). 6. Escarotomia antecedente l'arruolamento 7. Ustioni fortemente contaminate o infezioni pre-esistenti (Negli adulti: GBC 20.0 x 103 unita`/L; minori con eta` compresa tra 4 e 16 anni: GBC 25.0 x 103 unita`/L) 8. Segni che possano indicare inalazione di fumo 9. Condizioni generali del paziente secondo le quali la chirurgia e` controindicata 10. Prigionieri 11. Donne in stato di gravidanza (positive al test di gravidanza) o donne in allattamento 12. Diabete mellito scarsamente controllato (HbA1c > 9%) 13. Presenza di patologia cardio-polmonare (infarto del miocardio nelle 4 settimane antecedenti la lesione, ipertensione polmonare, malattia polmonare cronica ostruttiva o pre-esistenti patologie polmonari ossigeno dipendente) 14. Concomitanza di pre-esistenti patologie che interferiscono con la circolazione (patologia vascolare periferica, edema, linfoedema, intervento chirurgico ai linfonodi regionali, obesita`, vene varicose) 15. Presenza di condizioni che minacciano nel breve la vita del paziente (quali patologie che compromettono il sistema immunitario, trauma con pericolo di vita, grave patologia della coagulazione pre-esistente, patologia cardiovascolare, epatica o neoplastica) 16. Assunzione cronica di steroidi per via sistemica 17. Storia di allergia e/o nota sensibilita` all'ananas o alla papaina 18. Recenti tentativi di suicidio 19. Partecipazione ad un altro studio con farmaco sperimentale 20. Attuale abuso di alcol o droghe 21. Assunzione di analgesici che impediscono al paziente di comprendere gli obiettivi, la natura e lo svolgimento dello studio.

E.5 End points

E.5.1

Primary end point(s)

The two co-primary endpoints are % treated wound excised (by tangential/minor/Versajet excision) or dermabraded, in first surgery, and % treated wound autografted of deep partial wounds where the potential tissue-sparing effect may be seen. Wounds which are entirely full thickness or have full thickness areas are excluded from both these analyses. The secondary end points are treated wound excised (by tangential/minor/Versajet excision) or dermabraded, in first surgery, for all wounds; time to complete wound closure; timely eschar removal (debridement)and blood loss.

I due endopoints co-primari sono costituiti dalla % di ustioni trattate con escissione (escissione tangenziale/minore/con Versajet) o dermoabrasione come chirurgia primaria e, delle lesioni a spessore parziale profondo, la percentuale di lesione trattata autoinnestata dove e` possibile vedere il potenziale effetto sul risparmio tissutale. Le ustioni che sono interamente a spessore completo o hanno aree a spessore completo sono escluse da entrambe le analisi. Gli end-points secondari sono costituiti dalla ustione trattata escissa (mediante escissione tangenziale/minore/con Versajet) o dermoabrasa, in prima chirurgia per tutte le ustioni; il tempo per la completa chiusura della lesione, la rimozione tempestiva dell`escara (sbrigliamento) e la perdita ematica.

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

confronto con il trattamento standard

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

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

E.8.7

Trial has a data monitoring committee

Yes

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

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

Yes

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)

Yes

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

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 2008-10-20.

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

Yes

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

Yes

F.3.3.7.1

Details of other specific vulnerable populations

minori

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

180

F.4.2.2

In the whole clinical trial

270

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

2008-07-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-05-07

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2010-01-29

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