Clinical Trials Register

Summary
EudraCT Number:	2013-003784-56
Sponsor's Protocol Code Number:	NV012013
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-02-06
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2013-003784-56

A.3

Full title of the trial

An open, randomized, clinical trial parallel-controlled with Mycostatin oral suspension, evaluating the efficacy of Nystatin oral gel and Nystatin oral suspension in adult patients with oropharyngeal candidiasis.

Otevřené, randomizované, klinické hodnocení účinnosti přípravků Nystatin ústní gel a Nystatin perorální suspenze, paralelně kontrolované přípravkem Mycostatin orální suspenze u dospělých pacientů s orofaryngeální kandidózou.

A.3.1

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

Effectiveness evaluation of Nystatin gel and suspension for the treatment of candidiasis in the mouth by comparing with Mycostatin suspension.

Hodnocení účinnosti gelu a suspenze Nystatin při léčbě kandidózy v ústech porovnáním s přípravkem Mycostatin suspenze.

A.4.1

Sponsor's protocol code number

NV012013

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	VUAB Pharma a.s.
B.1.3.4	Country	Czech Republic
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	VUAB Pharma a.s.
B.4.2	Country	Czech Republic
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	VUAB Pharma a.s.
B.5.2	Functional name of contact point	Klára Kynčlová
B.5.3	Address:
B.5.3.1	Street Address	Vltavská 53
B.5.3.2	Town/ city	Roztoky
B.5.3.3	Post code	252 63
B.5.3.4	Country	Czech Republic
B.5.4	Telephone number	+420733695 601
B.5.6	E-mail	kkynclova@vuab.cz

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	Nystatin 100,000 IU/ml oral gel
D.3.4	Pharmaceutical form	Oral gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oromucosal use Oropharyngeal use Buccal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NYSTATIN
D.3.9.1	CAS number	1400-61-9
D.3.9.4	EV Substance Code	SUB03475MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU/g international unit(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	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	Nystatin 100,000 IU/ml oral suspension
D.3.4	Pharmaceutical form	Oral suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oromucosal use Oropharyngeal use Buccal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NYSTATIN
D.3.9.1	CAS number	1400-61-9
D.3.9.4	EV Substance Code	SUB03475MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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: 3
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	Mycostatin 100,000 IU/ml oral suspension
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Mycostatin 100,000 IU/ml oral suspension
D.3.4	Pharmaceutical form	Oral suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oromucosal use Oropharyngeal use Buccal use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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

Laboratory confirmed efficacy of Nystatin in pharmaceutical forms for buccal use, in patients with oropharyngeal candidiasis

Laboratorně potvrzená účinnost Nystatinu v lékových formách pro lokální užití v dutině ústní u pacientů s orofaryngeální kandidózou

E.1.1.1

Medical condition in easily understood language

Reducing the yeast amount after treatment with medicinal products Nystatin for buccal use, i.e. oral gel or oral suspension

Snížení množství kvasinek v ústech po léčbě s léčivými přípravky Nystatin určenými k orální-lokální léčbě, tj. ústní gel nebo perorální suspenze

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluation of the efficacy of Nystatin oral gel and Nystatin oral suspension compared to the reference medical product with the same active ingredient (nystatinum) in oral suspension form.

Zhodnocení účinnosti přípravku Nystatin ústní gel a Nystatin perorální suspenze srovnáním s referenčním léčivým přípravkem se stejnou účinnou látkou (nystatinum) ve formě perorální suspenze.

E.2.2

Secondary objectives of the trial

Evaluation of the safety of Nystatin oral gel and Nystatin oral suspension compared to the reference medical product with the same active ingredient (nystatinum) in oral suspension form.

Zhodnocení bezpečnosti přípravku Nystatin ústní gel a Nystatin perorální suspenze srovnáním s referenčním léčivým přípravkem se stejnou účinnou látkou (nystatinum) ve formě perorální suspenze.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects must have signed an approved informed consent after complete information
Subjects with oropharyngeal candidiasis (clinical and subjective: patient with moderate difficulties (requiring medical attention), clinical findings - plaque of moderate size and/or count); laboratory confirmed presence of Candida albicans at least widely abundance
Men and women aged 18 to 60 years.

Informovaný souhlas dobrovolně podepsaný po úplné informaci subjektu.
Subjekt s orofaryngeální kandidózou (klinicky i subjektivně: subjekt s minimálně průměrnými obtížemi (vyžadující lékařskou pomoc) s klinickým nálezem minimálně průměrných povlaků jak velikostí tak rozsahem); laboratorně prokázaná přítomnost Candida albicans v minimálně hojně-hojném množství
Muži i ženy ve věku 18 - 60 let.

E.4

Principal exclusion criteria

Subjects with oropharyngeal candidiasis with no laboratory confirmed the presence of Candida albicans at least widely abundance.
Subjects treated with antibiotics or antifungal medication for less than 7 days prior to screening.
Subjects under 18 years of age or older than 60 years.
Subjects with dentures.
Subject with acute infectious diseases.
Subject with confirmed clinical immunodeficiency.
Subject allergic to any of the substances of the investigational medicinal product administered in clinical trial.
Pregnant woman and breastfeeding (anamnestically).
Woman at fertile age without adequate contraception (barrier and hormonal) or without practicing sexual abstinence.
Inability of cooperation or irresponsibility.
Known or suspected history of alcoholism or drug abuse.
Unwillingness to sign informed consent.
Current participation in another clinical trial or in drug evaluation, within 4 weeks prior to study entry.
Dependents (eg soldiers, persons dependent on the researcher - such as subordinates, family members).

Subjekt bez laboratorně prokázané Candida albicans v množství nižším než „hojně-hojném“.
Subjekt léčený antimykotiky nebo antibiotiky kratší dobu než 7 dní před skríningem.
Subjekty mladší 18 let nebo starší 60 let.
Subjekty se zubní náhradou.
Subjekt s jiným akutním infekčním onemocněním.
Subjekt s prokazatelnou klinickou imunodeficiencí.
Subjekt alergický na některou ze složek klinicky hodnoceného a/nebo referenčního přípravku.
Gravidní žena a žena v laktaci (anamnesticky).
Žena ve fertilním věku bez adekvátní antikoncepce (bariérové, hormonální) nebo bez praktikování pohlavní abstinence.
Neschopnost spolupráce, nesvéprávnost.
Závislé na alkoholu, drogách.
Neochotné podepsat informovaný souhlas.
Subjekt současně účastnící se jiného klinického hodnocení léčiva či hodnocení, které se konalo v uplynulých 4 týdnech.
Závislé osoby (např. vojáci v základní službě, osoby závislé na výzkumníkovi – např. podřízení, rodinní příslušníci).

E.5 End points

E.5.1

Primary end point(s)

semiquantified Candida albicans load, determined from a sample withdrawn from mouth

semikvantifikovaná nálož Candida albicans, stanovená ze vzorku odebraného v dutině ústní

E.5.1.1

Timepoint(s) of evaluation of this end point

2 and 4 weeks after treatment beginning

2 a 4 týdny po zahájení léčby

E.5.2

Secondary end point(s)

subjective evaluation by subject and investigator
adverse events record and vital parameters

subjektivní hodnocení subjektem i zkoušejícím
výskytu nežádoucích příhod a vitální parametry

E.5.2.1

Timepoint(s) of evaluation of this end point

2 and 4 weeks after treatment beginning

2 a 4 týdny po zahájení léčby

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

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:

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

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

Žádné

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

2014-04-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-02-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-12-17

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials