Clinical Trials Register

Summary
EudraCT Number:	2017-003526-32
Sponsor's Protocol Code Number:	EQI7-16-02
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-11-04
Trial results	View 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

2017-003526-32

A.3

Full title of the trial

Randomised, double blind, parallel-groups, non-inferiority versus Flector¿ and superiority versus Placebo, Phase III clinical trial with Diclofenac Sodium 140 mg medicated plaster in patients with impact injuries of the limbs

Studio clinico di fase III, randomizzato, in doppio cieco, a gruppi paralleli, di non inferiorit¿ rispetto a Flector¿ e di superiorit¿ rispetto a placebo, sul cerotto medicato con 140 mg di diclofenac sodico in pazienti con lesioni traumatiche agli arti

A.3.1

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

Clinical trial with Diclofenac Sodium 140 mg medicated plaster in patients with impact injuries of the limbs

Studio clinico con un cerotto medicato a base di diclofenac sodico 140 mg in pazienti con traumi da impatto agli arti

A.3.2

Name or abbreviated title of the trial where available

Not available

Non disponibile

A.4.1

Sponsor's protocol code number

EQI7-16-02

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	FIDIA FARMACEUTICI S.P.A.
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	Fidia Farmaceutici S.p.A.
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	LB Research S.r.l.
B.5.2	Functional name of contact point	Flavia Baruzzi
B.5.3	Address:
B.5.3.1	Street Address	Via Lombardia 81
B.5.3.2	Town/ city	Cant¿
B.5.3.3	Post code	22063
B.5.3.4	Country	Italy
B.5.4	Telephone number	0039031734908
B.5.5	Fax number	00390317372218
B.5.6	E-mail	flavia.baruzzi@lbresearch.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	Diclofenac sodium 140 mg medicated plaster
D.3.2	Product code	EQI7
D.3.4	Pharmaceutical form	Transdermal patch
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous 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	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	Flector 180 mg cerotto medicato
D.2.1.1.2	Name of the Marketing Authorisation holder	IBSA Farmaceutici Italia Srl
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	Diclofenac epolamine
D.3.4	Pharmaceutical form	Transdermal patch
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	DICLOFENAC EPOLAMINUM
D.3.9.2	Current sponsor code	DICLOFENAC EPOLAMINE
D.3.9.4	EV Substance Code	SUB20558
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	180
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Transdermal patch
D.8.4	Route of administration of the placebo	Cutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with painful and phlogistic (inflammatory response) disease due to acute traumatic events (injury/contusion) of the limbs

Pazienti con dolore e infiammazione dovuti ad eventi traumatici acuti (trauma/contusione) a livello degli arti

E.1.1.1

Medical condition in easily understood language

Patients with painful injury/contusion of the limbs

Pazienti con trauma/contusione doloroso a livello degli arti

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10065016
E.1.2	Term	Post-traumatic pain
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 primary objective of this trial is to show non-inferior efficacy of Test Diclofenac Sodium 140 mg medicated plaster (once a day) over a Reference Diclofenac epolamine (DIEP) 180 mg medicated plaster, Flector¿ (once a day), and that both Test and Reference are superior to Placebo plaster (once a day) in improving pain at rest at 72 ¿ 2 hours (Day 4) after treatment start in patients with painful and phlogistic (inflammatory response) disease due to acute traumatic events (injury/contusion) of the limbs. A 100-mm Visual Analogue Scale (VAS) will be used for the assessment of pain at rest.

L¿obiettivo primario di questo studio ¿ di dimostrare la non-inferiorit¿ di efficacia del Test cerotto medicato di Diclofenac Sodico 140 mg (una volta al giorno) rispetto al prodotto di Riferimento cerotto medicato di Diclofenac epolamina (DIEP) 180 mg, Flector¿ (una volta al giorno) e che entrambi i prodotti Test e Riferimento sono superiori al cerotto Placebo (una volta al giorno) nel miglioramento del dolore a riposo dopo 72 ¿ 2 ore (Giorno 4) dall¿inizio del trattamento in pazienti con dolore e flogosi (risposta infiammatoria) dovuti a eventi traumatici acuti (trauma/contusione) agli arti. Per la valutazione del dolore a riposo verr¿ utilizzata una scala analogico visiva (VAS) da 100 mm.

E.2.2

Secondary objectives of the trial

The secondary objectives of the clinical trial are to evaluate:
¿ The efficacy of the Test product in comparison to Reference and Placebo with regard to pain relief (pain at rest and pain on movement), consumption of rescue medication and global assessment of efficacy by patient;
¿ The adhesion of the Test product in the site of application in comparison to Reference and Placebo;
¿ The general safety and local tolerability of the Test product in comparison to Reference and Placebo.

Gli obiettivi secondari dello studio clinico sono di valutare:
¿ L¿efficacia del prodotto Test rispetto al Riferimento e al Placebo per quanto riguarda il sollievo dal dolore (dolore a riposo e dolore al movimento), il consumo di farmaco di soccorso e la valutazione globale di efficacia da parte del paziente;
¿ L¿adesivit¿ del prodotto Test nel sito di applicazione rispetto al Riferimento e al Placebo;
¿ La sicurezza generale e la tollerabilit¿ totale del prodotto Test rispetto al Riferimento e al Placebo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients who meet all of the following criteria will be enrolled in the study:
1. Male or female, age range 18-65 years (included);
2. Patient with painful and phlogistic (inflammatory response) disease due to acute traumatic events (injury/contusion) of the limbs;
3. Patient with pain at rest in only one limb surface area affected by injury/contusion;
4. Written informed consent to participate in the study obtained according to GCP;
5. Patients able to comprehend the full nature and the purpose of the study, including possible risks and side effects, and able to cooperate with the Investigator and to comply with the requirements of the entire study (including ability to attend all the planned study visits according to the time limits), based on Investigator’s judgement;
6. Good general health as determined by the Investigator based on medical history and physical examination;
7. Female of child-bearing potential (i.e. not in menopausal status from at least one year or permanently sterilized) must have a negative urine pregnancy test prior the first IMP administration;
8. Presence of pain at rest in the injured area, defined by patient with a VAS =40 mm and =80 mm at Visit 1 on a 100 mm VAS.

Verranno arruolati nello studio i pazienti che soddisfano tutti i seguenti criteri:
1. Maschi o femmine, di età compresa tra 18 e 65 anni (inclusi);
2. Pazienti con dolore e flogosi (risposta infiammatoria) dovuti a eventi traumatici acuti (trauma/contusione) agli arti;
3. Pazienti con dolore a riposo in una sola area dell’arto affetta da trauma/contusione;
4. Consenso informato scritto a partecipare allo studio, ottenuto in accordo alle GCP;
5. Pazienti in grado di comprendere la completa natura e lo scopo dello studio, inclusi i possibili rischi e gli effetti collaterali, e in grado di cooperare con lo Sperimentatore e di ottemperare ai requisiti dell’intero studio (inclusa la possibilità di partecipare a tutte le visite di studio programmate secondo i termini), secondo il giudizio dello Sperimentatore;
6. Buono stato di salute generale determinato dallo Sperimentatore in base all’anamnesi e all’esame fisico;
7. Le donne in età fertile (ovvero non in menopausa da almeno un anno o permanentemente sterilizzate) devono avere un test di gravidanza su urine negativo prima della prima somministrazione del farmaco sperimentale;
8. Presenza di dolore a riposo nell’area interessata, definito dal paziente con un valore della VAS alla Visita 1 = 40 mm e = 80 mm, su una scala VAS da 100 mm.

E.4

Principal exclusion criteria

Patients who fulfil any of the following criteria will not be enrolled in the study:
1. Patient with a chronic painful or phlogistic disease (from more than three months);
2. Patient with painful or phlogistic disease arising from fractures or severe trauma events;
3. Pregnancy or lactation period throughout the whole study duration;
4. If female and of child-bearing potential, patient not using a highly effective method of birth control. Highly effective birth control methods include: combined hormonal contraception (containing estrogen and progestogen) associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence*;
5. Presence of concurrent skin disorders or open wounds in the area to be treated;
6. History of alcohol or drug abuse;
7. History of allergy or hypersensitivity or intolerance to diclofenac and/or to active or inactive excipients of formulation;
8. Known hypersensitivity to non-steroidal anti-inflammatory drugs and to paracetamol;
9. Use of non-steroid anti-inflammatory drugs and analgesics in the week before Visit 1 (with the exception of paracetamol, which should not be taken in the previous 8 hours), oral corticosteroids within 2 weeks or intravenous corticosteroids within 4 weeks before Visit 1. Chronic intake of small doses of acetylsalicylic acid (= 162 mg/day) taken for at least 30 days prior to the first dose of study medication for non-analgesic reasons may be continued (with no change on dosage) for the duration of the study;
10. Any other treatment or medication for the same or other indications that, according to its pharmacological properties and in the opinion of the Investigator, can alter the perception of pain (e.g. heparinoids or other anticoagulant agents, opioids, psychotropic agents, anti H1 agents or analgesics like glucocorticosteroids, etc.) in the week before Visit 1;
11. Any other concomitant treatment (e.g. cosmetics, ointments at the treated area) or medication that cannot be interrupted and interferes with the conduct of the trial;
12. History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days before Visit 1;
13. History of uncontrolled chronic or acute concomitant disease which, in the Investigator’s opinion, would contraindicate study participation or confound interpretation of the results;
14. Known malignant diseases in the last 5 years;
15. Pre-treatment of the traumatic event (injury/contusion) target of this study. Previous cooling (with ice, cooling spray) is authorized prior to Visit 1 (but not in the three hours preceding Visit 1);
16. Anticipated poor compliance by the patient;
17. Previous participation in this clinical trial;
18. Any relevant surgical treatment during the previous 2 months or planned during the trial;
19. Patient with a history of serious psychiatric disorders;
20. Participation in any other clinical study within 30 days prior to Visit 1.
*Note: According to 4.1 paragraph “Birth control methods which may be considered as highly effective” of the CTFG/Recommendations related to contraception and pregnancy testing in clinical trials

Non verranno arruolati nello studio i pazienti che presentano anche uno dei seguenti criteri:
1. Paziente con dolore e flogosi cronici (da più di tre mesi);
2. Paziente con dolore e flogosi derivanti da fratture o eventi traumatici gravi;
3. Donne in gravidanza o allattamento nel corso di tutto lo studio;
4. Se donna ed in età fertile, paziente che non usi un metodo contraccettivo altamente efficace. I metodi contraccettivi altamente efficaci comprendono: contraccezione ormonale combinata (contenente estrogeno e progesterone) associata ad inibizione dell’ovulazione (orale, intravaginale, transdermica); contraccezione ormonale (solo progesterone) associata ad inibizione dell’ovulazione (orale, iniettabile, impiantabile); dispositivo intrauterino (IUD); sistema intrauterino che rilascia ormoni (IUS); occlusione bilaterale delle tube; partner vasectomizzato; astinenza sessuale*;
5. Presenza di disturbi concomitanti a carico della cute o di ferite aperte nell’area da trattare;
6. Storia di abuso di alcool o droghe;
7. Storia di allergia o di ipersensibilità o intolleranza a diclofenac e/o a eccipienti attivi o inattivi della formulazione;
8. Ipersensibilità nota ai farmaci anti-infiammatori non steroidei e al paracetamolo;
9. Uso di farmaci anti-infiammatori non steroidei e analgesici nella settimana precedente la Visita 1 (ad eccezione di paracetamolo, che non dovrebbe essere assunto nelle 8 ore precedenti), di corticosteroidi orali entro le 2 settimane e intravenosi entro 4 settimane precedenti la Visita 1. L'assunzione cronica di piccole dosi di acido acetilsalicilico (= 162 mg/die), assunto per almeno 30 giorni prima della prima dose del farmaco in studio per motivi diversi dall’analgesia, potrà proseguire per tutta la durata dello studio (nessun cambio di dose);
10. Qualsiasi altro trattamento o farmaco per la stessa o per altre indicazioni che, in accordo alle sue proprietà farmacologiche e secondo l’opinione dello Sperimentatore, possa alterare la percezione del dolore (ad esempio eparinoidi o altri agenti anticoagulanti, oppioidi, agenti psicotropi, H1 antagonisti o analgesici come glucocorticosteroidi, ecc.), nella settimana precedente la Visita 1;
11. Qualsiasi altro trattamento concomitante (ad esempio cosmetici, pomate nella zona trattata) o farmaco che non possa essere interrotto e che interferisce con la conduzione dello studio;
12. Storia di ulcerazione esofagea, gastrica, del canale pilorico o duodenale, attiva o sospetta, o sanguinamento nei 30 giorni precedenti la Visita 1;
13. Storia di una patologia cronica non controllata o di una patologia acuta concomitante che, secondo l’opinione dello Sperimentatore, possa rappresentare una controindicazione per la partecipazione del paziente allo studio o confondere l'interpretazione dei risultati;
14. Malattie maligne note negli ultimi 5 anni;
15. Pre-trattamento dell’evento traumatico (trauma/contusione) in studio. Il raffreddamento precedente (con ghiaccio, spray di raffreddamento) è autorizzato prima della Visita 1 (ma non nelle 3 ore precedenti la Visita 1);
16. Previsione di scarsa aderenza alle procedure del protocollo di studio da parte del paziente;
17. Precedente partecipazione a questa sperimentazione;
18. Qualsiasi trattamento chirurgico rilevante durante i 2 mesi precedenti o pianificato durante lo studio;
19. Paziente con storia di disordini psichiatrici gravi;
20. Partecipazione a qualsiasi altro studio clinico nei 30 giorni precedenti la Visita 1.
*Nota: in accordo al paragrafo 4.1 "Metodi contraccettivi che possono essere considerati come altamente efficaci" del CTFG/raccomandazioni relative alla contraccezione e test di gravidanza in studi clinici.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in VAS score for pain at rest at 72 ± 2 hours (Day 4) after treatment start.

Variazione rispetto al basale del punteggio VAS per il dolore a riposo dopo 72 ± 2 ore dall’inizio del trattamento (Giorno 4).

E.5.1.1

Timepoint(s) of evaluation of this end point

72 hours ± 2 hours after treatment start

72 ore ± 2 ore dall'inizio del trattamento

E.5.2

Secondary end point(s)

Efficacy parameters
¿ Area under the curve (AUC) for pain at rest at Day 4 and Day 8 (SPID0-4d and SPID0-8d);
¿ Change from baseline of VAS for pain at rest at the other study time-points (including patients¿ home measurements);
¿ Time to resolution of pain at rest;
¿ Change from baseline in VAS score for pain on movement at 72 ¿ 2 hours (Day 4) and at 192 ¿ 2 hours (Day 8) after treatment start;
¿ Proportion of responder patients (defined as a decrease = 50% of baseline VAS for pain at rest and on movement) at 72 ¿ 2 hours (Day 4) after treatment start;
¿ Proportion of patients that will use rescue medication (paracetamol) and consumption of rescue medication during the entire study period;
¿ Global assessment of efficacy by patient, performed at 72 ¿ 2 hours (Day 4) and at 192 ¿ 2 hours (Day 8) after treatment start;
¿ Assessment of the adhesion of the medicated plaster IMP in the site of application, performed daily by patients and at 72 ¿ 2 hours (Day 4) and at 192 ¿ 2 hours (Day 8) after treatment by the ¿open¿ member of the staff.
Safety parameters
¿ Summaries of adverse events (AEs) and frequency of discontinuation of treatment due to AEs;
¿ Local tolerability (erythema, itching, burning and local pain) at the IMP application site;
¿ Investigator¿s and patient¿s opinion on local tolerability;
¿ Change from baseline in vital signs (blood pressure and heart rate);
¿ Abnormalities in the physical examination.

Parametri di efficacia
¿ Area sotto la curva (AUC) per il dolore a riposo al Giorno 4 e al Giorno 8 (SPID0-4g e SPID0-8g);
¿ Variazione della VAS per il dolore a riposo agli altri time-points dello studio (incluse le misurazioni effettuate a casa dai pazienti), rispetto al basale;
¿ Tempo di risoluzione del dolore a riposo;
¿ Variazione rispetto al basale del punteggio VAS per il dolore al movimento dopo 72 ¿ 2 ore (Giorno 4) e dopo 192 ¿ 2 ore (Giorno 8) dall¿inizio del trattamento;
¿ Proporzione di pazienti responder (definito come diminuzione = 50% della VAS rispetto basale per il dolore a riposo e al movimento) dopo 72 ¿ 2 ore (Giorno 4) dall¿inizio del trattamento;
¿ Proporzione di pazienti che utilizzer¿ il farmaco di soccorso (paracetamolo) e consumo di farmaco di soccorso durante l¿intero periodo dello studio;
¿ Valutazione globale dell¿efficacia da parte del paziente, effettuata dopo 72 ¿ 2 ore (Giorno 4) e dopo 192 ¿ 2 ore (Giorno 8) dall¿inizio del trattamento;
¿ Valutazione dell¿adesione del cerotto medicato con il farmaco sperimentale sul sito di applicazione, effettuata giornalmente dal paziente e dopo 72 ¿ 2 ore (Giorno 4) e dopo 192 ¿ 2 ore (Giorno 8) dall¿inizio del trattamento dal membro dello staff ¿in aperto¿;
Parametri di sicurezza
¿ Riepilogo degli Eventi Avversi (EA) e frequenza di interruzione del trattamento dovuto a EA.
¿ Tollerabilit¿ locale (eritema, prurito, bruciore e dolore locale) nel sito di applicazione del farmaco sperimentale;
¿ Opinione dello Sperimentatore e del paziente sulla tollerabilit¿ locale;
¿ Variazione nei segni vitali (pressione sanguigna e frequenza cardiaca) rispetto al basale;
¿ Anomalie nell¿esame fisico

E.5.2.1

Timepoint(s) of evaluation of this end point

It depends on the endpoint considered. See previous section.

Dipende dall'endpoint considerato. Vedi sezione precedente

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

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

Yes

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

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

LPLV

Ultima visita dell'ultimo paziente

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:

205

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.4.2

For a multinational trial

F.4.2.1

In the EEA

210

F.4.2.2

In the whole clinical trial

210

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)

None

Nessuno

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

2018-04-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-01-29

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
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