Clinical Trials Register

Summary
EudraCT Number:	2014-003757-33
Sponsor's Protocol Code Number:	027ic13250
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:	2015-05-13
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

2014-003757-33

A.3

Full title of the trial

Evaluation of the efficacy and safety of prulifloxacin vs levofloxacin in the treatment of Chronic Bacterial Prostatitis

A.3.1

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

Efficacy and safety of prulifloxacin in Chronic Bacterial Prostatitis

Efficacia e sicurezza di prulifloxacina nelle prostatiti croniche batteriche

A.3.2

Name or abbreviated title of the trial where available

Prulifloxacin in CBP

Prulifloxacina nelle prostatiti croniche batteriche

A.4.1

Sponsor's protocol code number

027ic13250

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	AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. 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	AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO SpA
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	AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.P.A.
B.5.2	Functional name of contact point	CTA unit
B.5.3	Address:
B.5.3.1	Street Address	Piazzale della Stazione s.n.c.
B.5.3.2	Town/ city	S.Palomba-Pomezia
B.5.3.3	Post code	00040
B.5.3.4	Country	Italy
B.5.4	Telephone number	06 91045335
B.5.5	Fax number	06 9194333
B.5.6	E-mail	g.orticelli@angelini.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.2.1.1.1	Trade name	UNIDROX - 600 MG COMPRESSE RIVESTITE CON FILM 10 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO ACRAF SPA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	prulifloxacina
D.3.2	Product code	027
D.3.4	Pharmaceutical form	Coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral 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	No
D.2.1.1.1	Trade name	LEVOXACIN - 500 MG COMPRESSE RIVESTITE CON FILM10 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	GLAXOSMITHKLINE 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	levofloxacina emiidrato
D.3.2	Product code	027
D.3.4	Pharmaceutical form	Coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral 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

Chronic Bacterial Prostatitis (CBP)

Prostatite cronica batterica

E.1.1.1

Medical condition in easily understood language

Prostatitis

Prostatite

E.1.1.2

Therapeutic area

Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	PT
E.1.2	Classification code	10069918
E.1.2	Term	Bacterial prostatitis
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the efficacy and safety of prulifloxacin in comparison to levofloxacin in the treatment of patients affected by Chronic Bacterial Prostatitis (CBP).

Valutare l'efficacia e la sicurezza di prulifloxacina in confronto a levofloxacina nel trattamento dei pazienti affetti da prostatite cronica batterica.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male between 18 and 50 years of age (limited included) with no limitation of race.
2. Patients presenting symptoms of prostatitis for at least 3 months.
3. Laboratory evidence of CBP at Visit 0 (Screening), assessed by Meares&Stamey four-glass test and defined as:
a. VB3 or EPS specimen containing ≥100 colony-forming units/ml of pathogen/s if the VB2 specimen is sterile;
or
b. VB3 or EPS specimen containing ≥100 colony-forming units/ml of pathogen/s that is different from any present in the VB2.
4. Medications for chronic prostatitis and/or medications that may affect bladder or prostate function (including but not limited to hormone therapy, anticholinergic or alpha blocker) must be discontinued at least 7 days before study drug intake.
5. Patients legally capable to give their consent to participate the study, and available to sign and date the written informed consent.

1. Uomini con età compresa tra i 18 e i 50 anni di età (limiti inclusi) senza limitazioni di razza.
2. Pazienti che presentano sintomi di prostatite per almeno 3 mesi.
3. Evidenza di laboratorio di prostatite cronica batterica a Visita 0 (Screening), valutata
tramite il test dei 4 bicchieri di Meares&Stamey e definita come:
a. Campione VB3 o EPS contenente ≥100 unità formanti colonia/ml di patogeno/i se il campione VB2 è sterile;
o
b. Campione VB3 o EPS contenente ≥100 unità formanti colonia/ml di patogeno/i differente/i da quello presente/i nel campione VB2.
4. Farmaci per prostatite cronica e/o farmaci che possono influenzare la funzionalità della vescica e della prostata (inclusi ma non limitati a terapia ormonale, anticolinergici o alfa-bloccanti) devono essere interrotti almeno 7 giorni prima l’inizio
del trattamento.
5. Pazienti legalmente capaci di dare il loro consenso a partecipare allo studio e disponibili a firmare e datare il consenso informato scritto.

E.4

Principal exclusion criteria

1. Known hypersensitivity or allergy to antibacterial fluoroquinolones and or to any components of the study medications.
2. Pathogen/s resistant to the study drugs at Visit 0 (Screening).
3. Suspicion for prostatic cancer, neurogenic bladder, Benign Prostatic Hypertrophy (BPH), bladder neck obstruction or urethral stricture.
4. Body Mass Index (BMI) < 16 kg/m2.
5. Immunocompromised patients.
6. Signs or symptoms or clinical documentation for concurrent infections (including but not limited to sexually transmitted infections) and/or neoplasm.
7. Clinically significant abnormalities on physical examination, vital signs, ECG,
laboratory tests at Visit 0 (Screening Visit).
8. Significant liver disease, defined as known active hepatitis or elevated liver enzymes > 3 times the upper boundary of the normal ranges.
9. Value of creatinine outside the normal ranges and judged clinically relevant by Investigator.
10. History of cardiac disease, including but not limited to myocardial infarction, heart failure, cardiomyopathy, cardiac hypertrophy, cardiac arrhythmias, bradycardia, cardiac conduction abnormalities, long QT syndrome.
11. Value of electrolytes (sodium, potassium, calcium, magnesium, chloride) outside the
normal ranges and judged clinically relevant by Investigator.
12. Patients under treatment with medications that may cause increase of the QT interval.
13. History of tendinopathy.
14. Patients with latent or known deficiencies for the glucose-6-phosphate dehydrogenase, or with hereditary problems of galactose intolerance or the Lapp lactase deficiency or glucose-galactose malabsorption.
15. Recent or past history of psychiatric illness or epilepsy.
16. Treatment with antibiotics or antibacterials within 2 weeks before study drug intake.
17. Treatment with experimental drugs (prulifloxacin or levofloxacin) or other fluoroquinolones within 4 weeks before study drug intake.
18. Diabetic patients in treatment with oral hypoglycemic drugs and insulin.
19. Patients under treatment with corticosteroids or Non-Steroidal Antiflammatory Drugs (NSAIDs).
20. Concomitant treatment with xanthines or anticoagulant drugs or drugs producing
hypokalemia or diuretics.
21. Positive history for drugs and alcohol abuse.
22. Inability to comply with the protocol requirements, instructions or study-related
restrictions (i.e. uncooperative attitude, inability to return for study-visits, improbability of completing the clinical study).
23. Vulnerable subjects (i.e. persons kept in detention).
24. Subject involved in the conduct of the study (i.e. Investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel).
25. Participation to an interventional clinical trial within 3 months prior to Visit 0 (Screening Visit).

1. Nota ipersensibilità o allergia agli antibiotici fluorochinoloni o a qualsiasi componente
dei farmaci in studio.
2. Patogeno/i resistente/i ai farmaci in studio a Visita 0 (Screening).
3. Sospetto di cancro prostatico, vescica neurogenica, ipertrofia prostatica benigna,
ostruzione del collo vescicale o restringimento uretrale.
4. Indice di massa corporea (BMI) < 16 kg/m2.
5. Pazienti immunocompromessi.
6. Segni o sintomi o documentazione clinica di infezioni concomitanti (incluse ma non limitate a infezioni sessualmente trasmissibili) e/o neoplasie.
7. Anormalità clinicamente significative dell’esame fisico, dei segni vitali, dell’ECG, degli esami di laboratorio a Visita 0 (Visita di Screening).
8. Patologia epatica significativa, definita come nota epatite attiva o enzimi epatici
maggiori di tre volte il limite superiore di normalità.
9. Valori di creatinina fuori i limiti di normalità e giudicati clinicamente significativi dallo Sperimentatore.
10. Storia di malattia cardiaca, inclusa ma non limitata a infarto del miocardio, insufficienza cardiaca, cardiomiopatia, ipertrofia cardiaca, aritmia cardiaca, bradicardia, anormalità della conduzione cardiaca, sindrome del QT lungo.
11. Valori di elettroliti (sodio, potassio, calcio, magnesio, cloro) al di fuori dei limiti di normalità e giudicati clinicamente rilevanti dallo Sperimentatore.
12. Pazienti sotto trattamento con farmaci che possono causare un aumento dell’intervallo QT.
13. Storia di tendinopatia.
14. Pazienti con deficit latenti o noti dell’enzima glucosio-6-fosfato deidrogenasi o con problemi ereditari di intolleranza al galattosio o con deficit di Lapp lattasi o malassorbimento di glucosio-galattosio.
15. Storia passata o recente di malattie psichiatriche o epilessia.
16. Trattamento con antibiotici o antibatterici nelle 2 settimane precedenti l’inizio del farmaco in studio.
17. Trattamento con i farmaci sperimentali (prulifloxacina o levofloxacina) o altri fluorochinoloni nelle 4 settimane precedenti l’inizio del farmaco in studio.
18. Pazienti diabetici in trattamento con farmaci ipoglicemizzanti orali e insulina.
19. Pazienti in trattamento con corticosteroidi e farmaci antinfiammatori non steroidei (FANSs).
20. Trattamento concomitante con xantine o farmaci anticoagulanti o farmaci che determinano ipokalemia o diuretici.
21. Storia positiva di abuso di droghe o alcool.
22. Incapacità ad aderire ai requisiti del protocollo, alle istruzioni o restrizioni correlate allo studio (i.e. attitudine non cooperativa, incapacità a ritornare alle visite previste, improbabilità di completare lo studio).
23. Soggetti vulnerabili (i.e. persone tenute in detenzione).
24. Soggetti coinvolti nella gestione dello studio (i.e. Sperimentatore o suo/sua delegato/a, primo grado di parentela, farmacista, assistente o altro personale).
25. Partecipazione ad uno studio clinico interventistico entro i 3 mesi prima della Visita 0
(visita di screening).

E.5 End points

E.5.1

Primary end point(s)

The microbiological efficacy assessed as eradication of prulifloxacin in comparison to levofloxacin.

Efficacia microbiologica valutata come eradicazione di prulifloxacina in confronto a levofloxacina.

E.5.1.1

Timepoint(s) of evaluation of this end point

Visit 3 (TOC Visit), 7 days (±2) after the end of treatment.

Visita 3 (TOC), 7 giorni (±2) dopo la fine del trattamento.

E.5.2

Secondary end point(s)

1 The microbiological efficacy assessed as eradication.
2 The microbiological efficacy assessed as eradication.
3 The clinical efficacy as assessed by NIH-CPSI reduction respect to Screening visit.
4 he clinical efficacy as assessed by NIH-CPSI reduction respect to Screening visit.
5 The clinical efficacy as assessed by NIH-CPSI reduction respect to Screening visit.
6 The safety and tolerability.

1 Efficacia microbiologica valutata come eradicazione.
2 Efficacia microbiologica valutata come eradicazione.
3 Efficacia clinica valutata come riduzione del NIH-CPSI rispetto alla visita Screening.
4 Efficacia clinica valutata come riduzione del NIH-CPSI rispetto alla visita Screening.
5 Efficacia clinica valutata come riduzione del NIH-CPSI rispetto alla visita Screening.
6 Sicurezza e tollerabilità.

E.5.2.1

Timepoint(s) of evaluation of this end point

1 Visit 4 (3 months after the end of treatment ±5 days).
2 Visit 5 (6 months after the end of treatment ±5 days).
3 Visit 3 (TOC Visit, 7 days (±2 days) after EOT).
4 Visit 4 (3 months after the EOT ±5 days).
5 Visit 5 (6 months after the EOT ±5 days).
6 During the study.

1 Visita 4 (3 mesi dopo la fine del trattamento ±5 giorni).
2 Visita 5 (6 mesi dopo la fine del trattamento ±5 giorni).
3 Visita 3 (TOC, 7 giorni (±2) dopo la fine del trattamento).
4 Visita 4 (3 mesi dopo la fine del trattamento ±5 giorni).
5 Visita 5 (6 mesi dopo la fine del trattamento ±5 giorni).
6 Durante lo studio.

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

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

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

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:

148

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

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

120

F.4.2

For a multinational trial

F.4.2.1

In the EEA

148

F.4.2.2

In the whole clinical trial

148

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)

The patients will be followed according to the current clinical practice.

I pazienti verranno seguiti come da normale pratica clinica.

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

2015-04-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-02-11

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

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