Clinical Trials Register

Summary
EudraCT Number:	2018-000656-18
Sponsor's Protocol Code Number:	2042015
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:	2018-10-11
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

2018-000656-18

A.3

Full title of the trial

Randomized, multi-center, double-blind, two-armed, parallel active groups, prospective trial, to evaluate, in pediatric population undergoing 'Calcaneo stop' surgery or Inguinal hernia repair, the efficacy and safety of chloroprocaine 1% and 2% for peripheral nerve block based on concentration–response relationships.

Studio prospettico, randomizzato, multicentrico, in doppio cieco, a due bracci e a gruppi attivi paralleli, per valutare, nella popolazione pediatrica sottoposta a intervento di 'calcaneo stop' o a riparazione dell'ernia inguinale, l'efficacia e la sicurezza di cloroprocaina all'1% e al 2% per il blocco nervoso periferico (BNP) in base alla relazione concentrazione-risposta.

A.3.1

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

Study to evaluate in children under 18 years of age the efficacy and safety of a local anesthetic used in flat foot interventions or inguinal hernia at two different concentrations (1% and 2%) administered to two separate groups of patients.

Studio per valutare nei bambini e nei ragazzi al di sotto dei 18 anni l’efficacia e la sicurezza di un anestetico locale usato in interventi di piede piatto o ernia inguinale a due diverse concentrazioni (1% e 2%) somministrate a due gruppi distinti di pazienti.

A.3.2

Name or abbreviated title of the trial where available

CHL.2/04-2015

A.4.1

Sponsor's protocol code number

2042015

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/014/2018

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	SINTETICA SA
B.1.3.4	Country	Switzerland
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	SINTETICA SA
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Link Neuroscience and Health Care srl - L.N.Age srl
B.5.2	Functional name of contact point	Clinical Operation
B.5.3	Address:
B.5.3.1	Street Address	Via Luigi Rizzo, 62
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00136
B.5.3.4	Country	Italy
B.5.4	Telephone number	0390639746749
B.5.5	Fax number	0390631077733
B.5.6	E-mail	info@lnage.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	Decelex
D.2.1.1.2	Name of the Marketing Authorisation holder	L. Molteni & C. dei F.lli Alitti Società di Esercizio 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.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Perineural use
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.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	Ampres
D.2.1.1.2	Name of the Marketing Authorisation holder	Sintetica SA
D.2.1.2	Country which granted the Marketing Authorisation	Switzerland
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	Chloroprocaine 2%
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Perineural use
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

Pediatric patients undergoing surgery of flatfoot or inguinal hernia

Pazienti in età pediatrica sottoposti ad intervento chirurgico di piede piatto o ernia inguinale

E.1.1.1

Medical condition in easily understood language

Pediatric patients undergoing surgery of flatfoot or inguinal hernia

Pazienti in età pediatrica sottoposti ad intervento chirurgico di piede piatto o ernia inguinale

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10002325
E.1.2	Term	Anesthesia local
E.1.2	System Organ Class	100000004865

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 primary objective of the study is the assessment of the efficacy of chloroprocaine 1% and 2%, administered by perineural, ultrasound-guided, injection in pediatric population for a successful peripheral nerve block (same volume ml/Kg) in terms of proportions of subjects not requiring rescue anesthesia during surgery.

L'obiettivo primario dello studio è la valutazione dell'efficacia di cloroprocaina all'1% e al 2%, somministrata nella popolazione pediatrica tramite iniezione perineurale ecoguidata, al fine di ottenere un efficace blocco nervoso periferico (stesso volume ml/kg) in termini di percentuale di soggetti che non necessitano di anestesia supplementare durante l'intervento.

E.2.2

Secondary objectives of the trial

•Time to onset of sensory block starting from completion of the Investigational Medicinal Products IMPs injection by the response to pinprick•time to onset of sensory block starting from completion of the IMPs injection•time to regression of motor block by standard Bromage scale, at the start of patient’s awakening, in case of calcaneo stop procedure•pain intensity assessed by the scales: COMFORT, FLACC, Wong-Baker•Time to eligibility for home discharge•if rescue anaesthesia (fentanyl) was required •time and dosage of rescue anaesthesia (fentanyl)•the general tolerability and safety assessed through summaries of adverse events•pain at injection site, neurological symptoms (such as: convulsions) and cardiac symptoms (such as bradycardia and heart failure etc.)

•Tempo necessario all'insorgenza del blocco sensoriale a partire dal termine dell'iniezione dei prodotti medicinali sperimentali tramite la risposta alla puntura di spillo•tempo necessario all'insorgenza del blocco sensoriale a partire dal termine dell'iniezione dei prodotti medicinali sperimentali•tempo alla regressione del blocco motorio mediante scala di Bromage standard, all'inizio del risveglio del paziente in caso di procedura di calcaneo stop•intensità del dolore valutata tramitele scale COMFORT, FLACC, Wong-Baker•tempo necessario a raggiungere i requisiti di ammissibilità alla dimissione•eventuale necessità di eseguire anestesia supplementare (fentanil) •durata e dosaggio dell'anestesia supplementare (fentanil) necessaria •la tollerabilità e la sicurezza valutate attraverso il riepilogo degli eventi avversi•il dolore nel sito di iniezione, i sintomi neurologici (ad es. convulsioni) e i sintomi cardiaci (tra cui bradicardia, insufficienza cardiaca, ecc.)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male and femalepaediatric patients from birth to <18 years scheduled for:
- 'calcaneo stop' surgery (6 to <18 years; children and adolescents)planned for sciatic nerve block short-lasting anaesthesia,
- inguinal hernia repair (0 to 6 years; newborn infants, infants-toddlers and children)planned for ilioinguinal/iliohypogastric block short-lasting anaesthesia;
2. Normally active and otherwise judged to be in good health on the basis of medical history, physical examination, with normal lean body mass (BMI18,5 – 24,9 Kg/m2 inclusive) and normal body development (normal weight and height according to local paediatric Height and Weight Chart);
3. ASA I and ASA II patients
4. Written informed consent provided by parents/tutor, willing and able to understand the purpose of the study, including possible risks and side effects, and willing and able to comply, on their behalf and of the minor, with the study requirements.
5. Willing and able to give additional written informed consent by itself, in case of children and adolescents, in addition to parents/tutor.
6. Willing and able, in case of children and adolescents, to comply with the study requirements on their behalf.

1. Pazienti pediatrici di sesso maschile e femminile, range di età dalla nascita a <18 anni, in attesa di:
- intervento di 'calcaneo stop' (da 6 a <18 anni; bambini e adolescenti) pianificato per anestesia a breve durata d'azione mediante blocco del nervo sciatico,
- riparazione dell'ernia inguinale (da 0 a 6 anni; neonati, lattanti, bambini ai primi passi e bambini) pianificata per anestesia a breve durata d'azione mediante blocco del nervo ileoinguinale/ileoipogastrico;
2. Normalmente attivi e altrimenti giudicati in buona salute sulla base di anamnesi medica ed esame obiettivo, con indice di massa corporea magra normale (BMI 18,5 - 24,9 kg/m2 inclusi) e normale sviluppo corporeo (peso e altezza nella norma secondo la tabella locale relativa a peso e altezza in età pediatrica);
3. Pazienti ASA I e ASA II;
4. Consenso informato scritto fornito da genitori/tutore, disposti e in grado di comprendere lo scopo dello studio, ivi inclusi i possibili rischi ed effetti collaterali, nonché disposti e in grado di soddisfare, personalmente e per conto del minore, i requisiti dello studio;
5. In caso di bambini e adolescenti, disposti e in grado di fornire personalmente un ulteriore consenso scritto informato in aggiunta a quello di genitori/tutore;
6. In caso di bambini e adolescenti, disposti e in grado di soddisfare personalmente i requisiti dello studio.

E.4

Principal exclusion criteria

1. ASA > II patients
2. Preexistent infection at injection site;
3. Use of opioids, antidepressants, anticonvulsant, sulfonamide, vasopressors, ergot-type oxytocic drug and mixtures of local anaesthetics, antiarrhythmic drug class III, such as amiodarone, strong inhibitors of CYP1A2, such as fluvoxamine and enoxacin;
4. Use of medication(s) known to interfere with the extent of regional blocks for 2 weeks before the start of the study;
5. History of drug or alcohol abuse;
6. Sensitivity among the study medication active ingredient, the members of the PABA esters group and amides-type local anesthetic group;
7. Clinical history of allergy, hypersensitivity or intolerance to the study medication or other medications used during surgery;
8. Pregnancy and lactation: positive pregnancy test at screening (if applicable), pregnant or lactating (the pregnancy test will be performed to all fertile subset)
9. Participation in any other clinical study within the 3 months prior to the screening.

1. Pazienti > ASA II;
2. Infezione preesistente nel sito di iniezione;
3. Uso di oppioidi, antidepressivi, anticonvulsivi, sulfonamidi, vasopressori, farmaci ossitocici derivati dall'ergotamina e miscele di anestetici locali, farmaci antiaritmici di classe III, ad es. amiodarone, forti inibitori del CYP1A2, tra cui fluvoxamina ed enoxacina;
4. Uso di farmaci di cui sia nota l'interferenza con l'estensione dei blocchi regionali per 2 settimane prima dell'inizio dello studio;
5. Precedenti di alcolismo o abuso di droghe;
6. Sensibilità tra il principio attivo del farmaco in studio, i componenti del gruppo di esteri PABA e il gruppo di anestetici locali di tipo amidico;
7. Anamnesi clinica di allergia, ipersensibilità o intolleranza al farmaco in studio o ad altri farmaci utilizzati durante l'intervento chirurgico;
8. Gravidanza e allattamento: test di gravidanza positivo allo screening (se applicabile), in stato di gravidanza o in allattamento (il test di gravidanza sarà eseguito su tutti i sottogruppi in età fertile);
9. Partecipazione a qualsiasi altro studio clinico nei 3 mesi precedenti lo screening.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint of the study will be represented by the overall proportion of patients, in each of the two dosage level groups, not requiring rescue anesthesia during surgery.

L'endpoint di efficacia primario dello studio sarà rappresentato dalla percentuale complessiva di pazienti, in ciascuno dei due gruppi dei livelli di dosaggio, che non necessitano di anestesia supplementare durante l'intervento chirurgico.

E.5.1.1

Timepoint(s) of evaluation of this end point

Day of surgery

Giorno dell’intervento chirurgico

E.5.2

Secondary end point(s)

Secondary efficacy endpoints:
The secondary efficacy endpoints of the trial will be evaluated, unless otherwise specified, on the two dosage level groups separately and, in both the two dosage level groups, on the two surgical procedures. Secondary efficacy endpoints will be:
1 Proportion of patients, in both of the two dosage level groups, not requiring rescue anaesthesia (fentanyl) during the two surgical procedures separately;
2 Time to onset of sensory block, defined as the time period from completion of the injection (time 0 min) to the achievement of complete sensory block, assessed by pin-prick test associated with heart rate measurement, and evaluated for both surgeries;
3 Time to regression of motor block evaluated in ‘calcaneo stop’ surgery only and assessed by a grade I of the standard Bromage scale (i.e. free movement of legs and feet). This evaluation will be performed immediately after the awakening and it will be repeated 30 minutes, 1 hour, 2 hours and 3 hours after the first evaluation, as well as during the visit for discharge
4 Pain intensity evaluated five times in the first 3 hours after patient’s awakening and during the home discharge visit (V2). Post-surgery assessment will be performed immediately after the awakening and it will be repeated 30 minutes, 1 hour, 2 hours and 3 hours after the firstevaluation. The technique and appropriate scale for pain measurement are age-dependent therefore, different tools will have to be used for the evaluation:
 COMFORT scale for patients <2 months of age;
 FLACC scale for patients aged ≥ 2 months ≤ 6 years;
 Wong-Baker scale for patients over 6 years of age;
5 Time to eligibility for home discharge, defined as: “the time elapsed from completion of surgery to the time when criteria for discharge are met, regardless if the patient will be discharged from the hospital at a later time, according to the hospital procedures”. The criteria for discharge will be defined according with the Pediatric Post Anesthesia Discharge Scoring System (Ped-PADSS)
6 Time from completion of IMP injection to rescue anaesthesia, whenever required
7 Posology of rescue anaesthesia, whenever required
8 Proportion of patients requiring additional analgesia after surgery, other than paracetamol 15 mg/kg i.v. administered during the surgery as per hospital’s standard procedures
9 Type and posology of rescue analgesia required during the 7 days after surgery for each one of the two surgical procedures

Secondary safety endpoints:
The secondary safety endpoints of the trial will be evaluated on the two dosage level groups separately and, in both the two dosage level groups, on the two surgical procedures, and will be:
10 Patient general recovery, evaluated by the Investigator through the evaluation questionnaire on the day of the intervention
11 Patient general recovery, evaluated by the Investigator or his deputy through the F.U 24 H evaluation questionnaire on the day after intervention
12 Patient general recovery, evaluated by the Investigator or his deputy through the F.U 7-day evaluation questionnaire 7 days after intervention
13 Overall proportion and 95% CI of patients with prolonged post-operative temporary loss of sensation and/or motor activity
14 Vital signs at rest (heart rate, systolic/diastolic blood pressure, respiratory rate, body temperature)
15 Proportion of patients with AE, in each of the two dosage level groups and in the two surgical procedures
16 Summaries of adverse events (AEs), including pain at injection site, neurological symptoms(such as: convulsion) and cardiac symptoms (such as bradycardia and heart failure etc.) evaluated, during surgery, after IMP injection

Endpoint di efficacia secondari:
Salvo quanto diversamente specificato, gli endpoint di efficacia secondari dello studio saranno valutati separatamente sui due gruppi dei livelli di dosaggio e, in entrambi i gruppi, sulle due procedure chirurgiche. Gli endpoint di efficacia secondari saranno:
1. Percentuale di pazienti, in entrambi i gruppi dei livelli di dosaggio, che non necessita di anestesia supplementare (fentanil) durante i due interventi chirurgici separatamente;
2. Tempo necessario all'insorgenza del blocco sensoriale, definito come il periodo di tempo che intercorre tra il termine dell'iniezione (0 min) e il raggiungimento del blocco sensoriale completo, determinato mediante test della puntura di spillo associato a misurazione della frequenza cardiaca e valutato per entrambi gli interventi chirurgici;
3. Tempo alla regressione del blocco motorio valutato unicamente nell'intervento di 'calcaneo stop' e definito dal grado I della scala di Bromage standard (ossia libera mobilità di gambe e piedi). Questa valutazione sarà eseguita subito dopo il risveglio e verrà ripetuta 30 minuti, 1 ora, 2 ore e 3 ore dopo questa prima valutazione, nonché durante la visita di dimissione
4. Intensità del dolore, valutata cinque volte nelle prime 3 ore successive al risveglio del paziente e durante la visita di dimissione (V2). La valutazione post-operatoria sarà eseguita subito dopo il risveglio e verrà ripetuta 30 minuti, 1 ora, 2 ore e 3 ore dopo la prima valutazione. Poiché la tecnica e la scala appropriata per la misurazione del dolore dipendono dall'età, per la valutazione si dovranno utilizzare strumenti diversi:
 Scala COMFORT per pazienti di età <2 mesi;
 Scala FLACC per pazienti di età ≥ 2 mesi e ≤ 6 anni;
 Scala Wong-Baker per pazienti di età superiore a 6 anni;
5. Tempo necessario a raggiungere i requisiti di ammissibilità alla dimissione, definito come segue: "tempo trascorso dal termine dell'intervento chirurgico fino al momento in cui vengono soddisfatti i criteri per la dimissione, indipendentemente dal fatto che il paziente sia dimesso dall'ospedale in un momento successivo secondo le procedure ospedaliere". I criteri di ammissibilità alla dimissione saranno definiti in base al sistema a punteggio per la dimissione post-anestesia in età pediatrica (Pediatric Post Anesthesia Discharge Scoring System, Ped-PADSS)
6. Tempo trascorso dal termine dell'iniezione del prodotto medicinale sperimentale fino all'anestesia supplementare, se necessaria
7. Posologia dell'anestesia supplementare, se necessaria
8. Percentuale di pazienti che necessitano di analgesia supplementare dopo l'intervento chirurgico, oltre a paracetamolo 15 mg/kg somministrato per via endovenosa durante l'intervento secondo le procedure standard dell'ospedale
9. Tipo e posologia dell'analgesia supplementare richiesta durante i 7 giorni successivi all'intervento per ciascuno dei due interventi chirurgici

Endpoint di sicurezza secondari:
Gli endpoint di sicurezza secondari dello studio saranno valutati separatamente sui due gruppi dei livelli di dosaggio e, in entrambi i gruppi, sulle due procedure chirurgiche; tali endpoint saranno:
10. Recupero generale del paziente, valutato dallo sperimentatore attraverso il questionario di valutazione il giorno dell'intervento
11. Recupero generale del paziente, valutato dallo sperimentatore o da un suo delegato attraverso il questionario di valutazione FU 24 H il giorno successivo all'intervento
12. Recupero generale del paziente, valutato dallo sperimentatore o da un suo delegato attraverso il questionario di valutazione FU 7-day dopo 7 giorni dall'intervento
13. Percentuale complessiva e IC al 95% di pazienti con perdita temporanea di sensibilità e/o attività motoria post-operatoria prolungata
14. Segni vitali a riposo (frequenza cardiaca, pressione arteriosa sistolica/diastolica, frequenza respiratoria, temperatura corporea)
15. Percentuale di pazienti con eventi avversi, in ciascuno dei due gruppi dei livelli di dosaggio e nelle due procedure chirurgiche
16. Riepilogo degli eventi avversi (AE), ivi inclusi dolore nel sito di iniezione, sintomi neurologici (ad es. convulsioni) e sintomi cardiaci (tra cui bradicardia, insufficienza cardiaca, ecc.), valutati durante l'intervento chirurgico dopo l'iniezione di IMP

E.5.2.1

Timepoint(s) of evaluation of this end point

• 1-8, 10, 12, 13, 14, 15, 16: Day surgery
• 9, 15, 16: after 7 days of surgery
• 11: day after surgery

• 1-8, 10, 12, 13, 14, 15, 16: Giorno dell’intervento chirurgico
• 9, 15, 16: durante i 7 giorni seguenti all’intervento chirurgico
• 11: giorno seguente all’intervento chirurgico

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

Yes

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

Yes

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

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

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

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

Phone follow up by the experimental center to the patient 7 (-1 / + 2) days following the surgery

Follow up telefonico da parte del centro sperimentale al paziente 7 (-1/+2) giorni seguenti l’intervento chirurgico

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:

174

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)

Yes

F.1.1.3.1

Number of subjects for this age range:

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

125

F.4.2

For a multinational trial

F.4.2.1

In the EEA

174

F.4.2.2

In the whole clinical trial

174

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)

At the discretion of the Investigator following the patient

A discrezione dello Sperimentatore che segue il paziente

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

2018-11-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-10-08

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

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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