Clinical Trials Register

Summary
EudraCT Number:	2014-003040-12
Sponsor's Protocol Code Number:	TZSA2
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:	2014-07-23
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

2014-003040-12

A.3

Full title of the trial

A phase III, multicenter, randomized, parallel groups study to assess the efficacy and safety of 0,5 mg Tizaspray® administered intranasally versus Sirdalud® 2 mg tablets, in patients with acute low back pain

Studio clinico di fase III, multicentrico, randomizzato, a gruppi paralleli per valutare l’efficacia e la sicurezza di Tizaspray® 0.5 mg somministrato per via intranasale versus Sirdalud® 2 mg compresse, nel trattamento del mal di schiena acuto

A.3.1

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

A.4.1

Sponsor's protocol code number

TZSA2

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	MDM 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	MDM 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	MDM S.p.A.
B.5.2	Functional name of contact point	Servizio Segreteria MDM
B.5.3	Address:
B.5.3.1	Street Address	Via Volturno, 29/b
B.5.3.2	Town/ city	MONZA (MI)
B.5.3.3	Post code	20052
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 039 3909110
B.5.5	Fax number	+39039 322888
B.5.6	E-mail	mdm@mdmspa.com

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	Tizaspray
D.3.2	Product code	Tizaspray
D.3.4	Pharmaceutical form	Nasal spray, solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intranasal use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Tizanidine hydrochloride
D.3.9.1	CAS number	64461-82-1
D.3.9.2	Current sponsor code	Tizaspray
D.3.9.3	Other descriptive name	TIZANIDINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB04895MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8.169
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	SIRDALUD 2 mg compresse
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Farma S.p.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	SIRDALUD 2 mg compresse
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TIZANIDINE
D.3.9.1	CAS number	64461-82-1
D.3.9.3	Other descriptive name	TIZANIDINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB04895MIG
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	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	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

Acute low back pain

Mal di schiena acuto

E.1.1.1

Medical condition in easily understood language

Acute low back pain

Mal di schiena acuto

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	17.0
E.1.2	Level	LLT
E.1.2	Classification code	10024891
E.1.2	Term	Low back pain
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

1)To evaluate the muscle relaxant activity of Tizaspray 0.5 mg compared to Sirdalud 2 mg tablets as assessed by the “hand-to-floor” distance at baseline, day 3 and day 8.2)To evaluate the efficacy of Tizaspray 0.5 mg for the treatment of acute low back pain compared to Sirdalud 2 mg tablets as assessed by the Low Back Pain Intensity Scale (VAS) over maximum 7 days of treatment. 3)To evaluate the muscle relaxant activity of Tizaspray 0.5 mg compared to Sirdalud 2 mg tablets as assessed by the Schober test (positive/negative) at baseline, day 3 and day 8.

1)Valutare l'attività miorilassante di Tizaspray 0,5 mg rispetto al Sirdalud 2mg compresse misurata dalla distanza "hand to floor" al basale, il giorno 3 e il giorno 8.2)Valutare l’efficacia di Tizaspray 0.5 mg rispetto al Sirdalud 2 mg compresse, per il trattamento di mal di schiena acuto tramite la Low Back Pain Intensity Scale (VAS)per un massimo di 7 giorni di trattamento.3)Valutare l'attività miorilassante di Tizaspray 0,5 mg rispetto al Sirdalud 2 mg compresse, tramite il test di Schober (positivo/negativo) al basale, il giorno 3 e il giorno 8.

E.2.2

Secondary objectives of the trial

1)To evaluate the efficacy of Tizaspray 0.5 mg for the treatment of acute low back pain compared to Sirdalud 2 mg tablets as assessed by the Patient’s Pain Relief Evaluation on days 3 and 8. 2)To determine the efficacy of Tizaspray 0.5 mg compared to Sirdalud 2 mg tablets at 30, 60, 90 and 180 minutes after the second administration (on day 1, 2 and 3) as assessed by the Low Back Intensity Scale (0 to 100 mm VAS).3)To evaluate the efficacy of Tizaspray 0.5 mg for the treatment of acute low back pain compared to Sirdalud 2 mg tablets, as measured by the Roland Disability Questionnaire on days 3 and 8.4)To evaluate the muscle relaxant activity of Tizaspray 0.5 mg compared to Sirdalud 2 mg tablets as assessed by the Schober test difference in cm between day 1 and day 3 and between day 1 and day 8.5)To evaluate the use of rescue medication for low back pain. Safety Objectives: To investigate the systemic, local safety and tolerability of Tizaspray 0.5 mg administered t.i.d.

1)Valutare l’efficacia di Tizaspray 0.5 mg rispetto al Sirdalud 2 mg compresse, per il trattamento di mal di schiena acuto tramite la Patient’s Pain Relief Evaluation, il giorno 3 e il giorno 8.2)Determinare l'efficacia di Tizaspray 0,5 mg rispetto al Sirdalud 2 mg compresse a 30, 60, 90 e 180 minuti dopo la seconda somministrazione (il giorno 1, 2 e 3), tramite la Low Back Pain Intensity Scale (VAS).3)Valutare l’efficacia di Tizaspray 0.5 mg rispetto al Sirdalud 2 mg compresse, per il trattamento di mal di schiena acuto tramite la Roland Disability Questionnaire il giorno 3 e il giorno 8.4)Valutare l'attività miorilassante di Tizaspray 0,5 mg rispetto al Sirdalud 2 mg compresse tramite la differenza in cm al Schober test, tra il giorno 1 e il giorno 3 e tra il giorno 1 e il giorno 8.5)Calcolare l’uso di rescue medication per il mal di schiena.Obiettivi di sicurezza: Studiare la sicurezza sistemica, locale e la tollerabilità di Tizaspray 0,5 mg somministrata 3 volte al giorno

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age between 18 and 65 years old
2. Average low back pain intensity moderate to severe (≥ 60 mm in the VAS) at Visit 1
3. Positivity to Schober test (i.e. measure < 5 cm) at Visit 1
4. Acute low back pain started at least 48 hours prior to inclusion in the trial and more than 6 weeks after the last episode of acute low back pain
5. Negative pregnancy test for women of childbearing potential (to be performed at Visit 1) and use of an acceptable mean of contraception (condom or mechanical methods) in the previous 2 months and for whole duration of the study
6. Signed Informed Consent

1. Età tra i 18 e i 65 anni
2. Intensità del dolore del mal di schiena da moderata a grave (> 60 mm nella VAS) alla visita 1
3. Test di Schober positivo (< 5 cm) alla visita 1
4. Esordio di mal di schiena almeno 48 ore prima dell’inclusione allo studio e più di 6 settimane dopo l’ultimo episodio
5. Test di gravidanza negativo per le donne in età fertile (da effettuare alla Visita 1) e l’uso di un mezzo accettabile di contraccezione (preservativo o metodi meccanici) nel corso degli ultimi 2 mesi e per tutta la durata dello studio
6. Consenso Informato firmato

E.4

Principal exclusion criteria

1. History of chronic low back pain
2. Current treatment with drugs having significant effects at the alpha2 receptors whether agonist (i.e., clonidine, methyldopa) or antagonist (i.e., phenothiazines, imipramine)
3. Current treatment with any other muscle relaxant or any drugs having muscle relaxant properties
4. Known allergies, hypersensitivity, or intolerance to tizanidine or paracetamol or any excipients used in their manufacture (included patients with known rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption)
5. Signs of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety
6. Evidence of clinically unstable disease, as determined by medical history, physical examination, that, in the Investigator's opinion, preclude entry into the study
7. Spinal surgery within 1 year of study entry
8. Evidence of clinical gastrointestinal malabsorption
9. Use of steroids within 3 months of study entry or any other long-term treatment with steroids
10. Use of NSAID’s or other anti-inflammatory drugs 6 hours prior to study inclusion
11. Use of fluvoxamine or ciprofloxacin, or other inhibitors of CYP1A2 such as antiarrhythmics (amiodarone, mexiletine, propafenone), cimetidine, fluoroquinolones (enoxacin, pefloxacin, norfloxacin), rofecoxib, oral contraceptives, and ticlopidine
12. Use of hypnotics or other CNS depressants
13. Blood pressure <100/70 mmHg and/or treated with antihypertensive drug
14. History of lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis
15. Severe scoliosis
16. More severe pain in a region other than the lower back
17. Acute low back pain associated with chills or fever
18. Pregnancy, breast feeding
19. Treatment with another investigational agent within the last 30 days
20.Known or suspected history of alcohol or drug abuse based on medical history, physical examination, or the Investigator's clinical judgment

1. Storia di mal di schiena cronico
2. Uso concomitante con farmaci che hanno effetti significativi a livello dei recettori alfa-2, agonisti (clonidina, metildopa), o antagonisti (fenotiazina, imipramina)
3. Uso concomitante con qualsiasi altro miorilassante o farmaci con proprietà miorilassanti
4. Allergie note, ipersensibilità o intolleranza alla tizanidina o al paracetamolo o ad uno qualsiasi degli eccipienti (inclusi pazienti affetti da rari problemi ereditari di intolleranza al galattosio, da deficit di Lapp lattasi, o da malassorbimento di glucosio-galattosio)
5. Segni di congestione nasale, polipi nasali, lesioni della mucosa nasale, scolo retronasale di qualsiasi eziologia o altra patologia nasale clinicamente significativa che può influenzare l'assorbimento del farmaco in studio o la valutazione della sicurezza
6. Soggetti che presentano condizioni cliniche instabili basate sull’anamnesi e sull’esame fisico e che secondo il giudizio dello sperimentatore precludono la partecipazione allo studio
7. Chirurgia vertebrale entro 1 anno dall’entrata allo studio
8. Evidenza clinica di malassorbimento gastrointestinale
9. Uso di farmaci steroidei nei 3 mesi precedenti dall’entrata allo studio o qualsiasi trattamento con steroidi a lungo termine
10. Uso di FANS o altri farmaci antinfiammatori 6 ore prima dall’inclusione allo studio
11. Uso di fluvoxamina o ciprofloxacina o di altri inibitori del citocromo P450 1A2 come alcuni antiaritmici (amiodarone, mexiletina, propafenone), cimetidina, alcuni fluorochinoloni (enoxacina, pefloxacina, norfloxacina), rofecoxib, contracettivi orali e ticlopidina
12. Uso di ipnotici o altri deprimenti del SNC
13. Pazienti con valori di pressione arteriosa <100/70 mmHg e/o trattati con farmaci antipertensivi
14. Storia di stenosi spinale lombare, fibromialgia, o spondilite anchilosante
15. Scoliosi di grado severo
16. Dolore più intenso in regione diversa da quella lombare
17. Lombalgia acuta associata a brividi o febbre
18. Gravidanza, allattamento
19. Pazienti che abbiano preso parte ad altre sperimentazioni cliniche nei 30 giorni precedenti
20. Nota o sospetta storia di abuso di alcol o di droghe basata sull’anamnesi, sull’esame fisico o sulla valutazione clinica dello sperimentatore

E.5 End points

E.5.1

Primary end point(s)

1) “Hand-to-floor” distance (evaluated at day 1, day 3 and day 8)
2) Low Back Pain Intensity Scale (0 to 100 mm VAS) over 7 days of treatment: daily evaluations of the pain intensity during movement, at rest and at night through the patient’s diary and evaluation of the pain intensity at visits.
3) Proportion of subjects with negative Schober test at day 3 and day 8

1) Distanza “Hand-to-floor” (valutata al giorno 1, giorno 3 e giorno 8)
2) Low Low Back Pain Intensity Scale (da 0 a 100 mm VAS) per un massimo di 7 giorni di trattamento: valutazioni quotidiane della intensità del dolore durante il movimento, a riposo e durante la notte attraverso il diario del paziente e la valutazione dell'intensità del dolore durante le visite.
3) Percentuale di soggetti con test di Schober negativo (valutato al giorno 3 e giorno 8)

E.5.1.1

Timepoint(s) of evaluation of this end point

1) At day 1, day 3 and day 8
2) Over 7 days
3) At day 3 and day 8

1) Al giorno 1, giorno 3 e giorno 8
2) Per un massimo di 7 giorni
3) Al giorno 3 e giorno 8

E.5.2

Secondary end point(s)

1) Patient’s Pain Relief Evaluation (improvement in pain from baseline to days 3 and 8)
2) Low Back Pain Intensity Scale (0 to 100 mm VAS) at 30, 60, 90 and 180 minutes after the second administration on days 1, 2 and 3
3) Roland Disability Questionnaire (RDQ) score on day 1, day 3 and day 8
4) Schober test difference in cm between day 1 and day 3 and between day 1 and day 8
5) Use of “rescue medication” (paracetamol) for low back pain
Safety / tolerability endpoints:
1) Incidence, type, and severity of adverse events
2) Laboratory tests changes, in terms of normal, abnormal non-clinically significant and abnormal clinically significant values
3) Patient’s Global Tolerability Evaluation assessed on day 8

1) Patient’s Pain Relief Evaluation (sollievo dal dolore dalla baseline al giorno 3 e al giorno 8)
2) Low Back Pain Intensity Scale (da 0 a 100 mm VAS) a 30, 60, 90 e 180 minuti dopo la seconda somministrazione (il giorno 1, 2 e 3)
3) Roland Disability Questionnaire (RDQ) score il giorno 1, il giorno 3 e il giorno 8
4) Differenza in cm al Schober test, tra il giorno 1 e il giorno 3 e tra il giorno 1 e il giorno 8
5) Uso di “rescue medication” (paracetamolo) per il mal di schiena acuto.
Valutazioni di sicurezza:
1) Incidenza, tipo e gravità degli eventi avversi
2) Variazioni degli esami di laboratorio, in termini di valori normali, anormali non-clinicamente significativi e anormali clinicamente significativi;
3) Valutazione globale della tollerabilità da parte del paziente valutata al giorno 8.

E.5.2.1

Timepoint(s) of evaluation of this end point

1) At day 3 and day 8
2) After the second administration on days 1, 2 and 3
3) At day 1, day 3 and day 8
4) At day 1, day 3 and day 8
5) At day 8
Safety / tolerability endpoints:
1) At day 1, day 3 and day 8
2) At day 1 and day 8
3) At day 8

1) al giorno3 e al giorno 8
2) Dopo la seconda somministrazione (il giorno 1, 2 e 3)
3) Al giorno 1, giorno 3 e giorno 8
4) Al giorno 1, giorno 3 e giorno 8
5) Al giorno 8
Valutazioni di sicurezza:
1) Al giorno 1, giorno 3 e giorno 8
2) Al giorno 1 e giorno 8
3) Al giorno 8

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Sirdalud 2 mg compresse

Sirdalud 2 mg tablet

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

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

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

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:

200

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

224

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

2014-09-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-10-02

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

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