Clinical Trials Register

Summary
EudraCT Number:	2011-003147-22
Sponsor's Protocol Code Number:	GLBR-101-2011
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-08-19
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

Spain - AEMPS

A.2

EudraCT number

2011-003147-22

A.3

Full title of the trial

A Multicenter, Open-Label, Comparator-Controlled, Parallel Group, Phase 3 Study to Assess the Efficacy and Safety of Clotrimazole/Clindamycin (200 mg/100 mg FDC) Ovules Compared with Metronidazole (500 mg) Plus Nystatin (100,000 IU) Vaginal Cream for the Treatment of Mixed Vaginitis

Estudio fase 3, con control activo, grupos paralelos, abierto y multicéntrico para evaluar la eficacia y la seguridad de los óvulos de clotrimazol/clindamicina (200 mg/100 mg ADF) en comparación con crema vaginal de metronidazol (500 mg) y nistatina (100.000 UI) en el tratamiento de la vaginitis de etiología mixta.

A.3.1

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

Clinical Trial Phase3 Study to Assess the Efficacy and Safety of Clotrimazole/Clindamycin Ovules Compared with Metronidazole Plus Nystatin Vaginal Cream for the Treatment of Mixed Vaginitis

Estudio fase 3, con control activo,con grupos paralelos, abierto y se hará en varios centros para evaluar la eficacia y la seguridad de los óvulos de clotrimazol/clindamicina en comparación con crema vaginal de metronidazol y nistatina en el tratamiento de la vaginitis mixta.

A.3.2

Name or abbreviated title of the trial where available

Clinical trial with pararell groups to Assess the Efficacy of a treatment for vaginitis

Estudio clinico con grupos paralelos para evaluar la eficacia de un tratamiento de vaginitis

A.4.1

Sponsor's protocol code number

GLBR-101-2011

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	Glenmark Farmaceutica LTDA
B.1.3.4	Country	Brazil
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	Glenmark Farmaceutica LTDA
B.4.2	Country	Brazil
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Quantum Experimental S.L.
B.5.2	Functional name of contact point	Anna Jurczynska
B.5.3	Address:
B.5.3.1	Street Address	Avda. M 40 17 Ofic.68
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28925
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34914855347
B.5.5	Fax number	+34914855409
B.5.6	E-mail	ajurczynska@quantumexperimental.es

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	Clotrigel C
D.3.4	Pharmaceutical form	Pessary
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Vaginal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	23593-75-1
D.3.9.3	Other descriptive name	CLOTRIMAZOLE
D.3.9.4	EV Substance Code	SUB06777MIG
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	200
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CLINDAMYCIN
D.3.9.1	CAS number	18323-44-9
D.3.9.4	EV Substance Code	SUB06665MIG
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	100
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

vaginitis

E.1.1.1

Medical condition in easily understood language

vaginitis

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	LLT
E.1.2	Classification code	10046950
E.1.2	Term	Vaginitis
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 evaluate the efficacy and safety of clotrimazole/clindamycin 200 mg/100 mg FDC) ovules in the treatment of mixed vaginitis.The primary efficacy endpoint is the Therapeutic Cure, defined as the subject achieving all 3 cures, i.e., Clinical, Mycological, and Bacterial Cures

El objetivo principal es evaluar la eficacia de los óvulos de clotrimazol/clindamicina (200 mg/100 mg, ADF) en el tratamiento de la vaginitis de etiología mixta.El criterio principal de valoración de la eficacia es la curación terapéutica, definida como la paciente que logra las 3 curaciones, es decir, clínica, micológica, y bacteriana

E.2.2

Secondary objectives of the trial

A secondary objective is to evaluate the safety of the eggs of clotrimazole / clindamycin (200 mg/100 mg, ADF) in the treatment of vaginitis of mixed etiology.

Como objetivo secundario se va a evaluar la seguridad de los óvulos de clotrimazol/clindamicina (200 mg/100 mg, ADF) en el tratamiento de la vaginitis de etiología mixta.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Female subjects aged ?18 and ?60 years.
Subjects who provide a written Informed Consent, which includes agreement to comply with all protocol-indicated study requirements, including a negative UPT for those of child-bearing potential.
Subjects deemed reliable and mentally competent to complete the study by the study personnel.
Subjects with a diagnosis of symptomatic mixed vaginitis, defined as having the following:
?Bacterial vaginosis (BV), as evidenced by:
?the presence of clue cells ?20% of the total epithelial cells on microscopic examination of a saline wet mount
?off-white (milky or gray), thin, homogeneous discharge with minimal or absent pruritus and inflammation of the vulva and vagina
?vaginal secretion with a pH of >4.5
?a fishy odor of the vaginal discharge with the addition of a drop of 10% potassium hydroxide (KOH) (i.e., a positive whiff test)
?a Gram?s stain Nugent Score of ?7 in the absence of clue cells and ?4 in the presence of clue cells
?Vulvovaginal candidiasis (VVC), as evidenced by:
?Clinical signs and symptoms including itching, burning, irritation, edema, erythema, and/or excoriation of the vagina and/or the vulva
?A 10% KOH test of vaginal discharge which demonstrates yeast forms (hyphae/pseudohyphae) or budding yeasts Subjects must agree to abstain from sexual intercourse for the duration of study treatment (either 3 or 10 days). Following the treatment period and until Visit 2, subjects must agree to use a non-lubricated condom when engaging in sexual intercourse.Subjects must agree to refrain from the use of intravaginal products throughout the study (e.g., douches, feminine deodorant sprays, spermicides, lubricated condoms, tampons, nonoxynol-9 [N-9] products, and diaphragms).
Subjects must agree to abstain from alcohol for the duration of study treatment and at least 2 days post-study treatment (at least 5 or 12 days).

Mujeres mayores de 18 años y menores de 60, pacientes que otorguen un consentimiento informado por escrito, que incluya el compromiso de cumplir todos los requisitos del estudio indicados en el protocolo, entre otros un test de embarazo en orina negativo (TEO) en el caso de mujeres en edad fértil, pacientes con diagnóstico de vaginitis de etiología mixta sintomática, definida como la presencia de lo siguiente:
?Vaginosis bacteriana, demostrada por:
?presencia de ?20% de células clave del total de células epiteliales en la exploración microscópica de un frotis húmedo con solución salina
?leucorrea blancuzca (lechosa o gris) homogénea, delgada, con prurito mínimo o ausente e inflamación de la vulva y la vagina
?secreción vaginal con un pH de >4,5
?flujo vaginal con olor a pescado al añadir una gota de hidróxido potásico (KOH) al 10% (es decir, una prueba del olfato [whiff test] positiva)
?puntuación de Nugent de la tinción de Gram ?7 en ausencia de células clave y ?4 en presencia de estas.
?Vaginosis bacteriana, demostrada por:
?Signos y síntomas clínicos como prurito, escozor, irritación, edema, eritema o excoriación de la vagina, de la vulva o de ambas
?Una prueba del flujo vaginal con KOH al 10% que demuestre formas de levaduras (hifas o pseudohifas) o levaduras en gemación.
Las pacientes se tienen que comprometer a no mantener relaciones sexuales durante el tratamiento del estudio (3 ó 10 días). Después del periodo de tratamiento y hasta la visita 2, las pacientes tienen que comprometerse a usar un preservativo sin lubricar cuando mantengan relaciones sexuales.
Las pacientes tienen que comprometerse a no usar productos intravaginales durante todo el estudio (p. ej., duchas vaginales, desodorantes femeninos en aerosol, espermicidas, preservativos lubricados, tampones, productos con nonoxinol-9 [N-9] y diafragmas).
Las pacientes tienen que comprometerse a no tomar alcohol durante el tratamiento del estudio y como mínimo hasta dos días después de este (al menos 5 ó 12 días).

E.4

Principal exclusion criteria

Subjects who are pregnant or breast feeding at the time of Day 0 or intend on becoming pregnant during the study.
Subjects suffering from a disease or disorder (e.g., diabetes, an immunodeficiency disorder [such as Human Immunodeficiency Virus (HIV) infection]) that predisposes her to recurrent mycological infection.
Subjects who have a gynecological condition contraindicating the use of intravaginal ovules or creams.
Subjects on current therapy with immunosuppressants and/or corticosteroids.
Subjects who used intravaginal or systemic antimicrobial therapy within 14 days of Day 0.
Subjects who used intravaginal or systemic antifungal therapy within 7 days of Day 0.
Subjects with other infectious causes of vaginitis (e.g., Trichomonas vaginalis [or any other protozoa], Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex, or human papilloma virus [HPV]) as confirmed by the rapid diagnostic test FemLab® Vaginitis Test Kit, which will be done at Screening.
Subjects with another vaginal or vulvar condition that would confound the interpretation of the clinical response.Subjects who have any vaginal bleeding.
Subjects who are anticipating menses during the study treatment period (the next 10 days).
Subjects receiving treatment or surgery during the study period for cervical intraepithelial neoplasia (CIN) or cervical carcinoma.
Subjects receiving treatment for anticoagulation (e.g., coumadin, warfarin) during the four weeks prior to Day 0, with the exception of low-dose aspirin (maximum 100 mg/day) for use as a cardiovascular prophylaxis.
Subjects with a known allergy or sensitivity to any of the study drugs, components or derivatives of the formulation excipients, or with chemically related similar drugs or formulation additives.
Subjects who took disulfuram within 14 days of Day 0.
1Subjects who used any investigational agent within 30 days of Day 0.
Subjects who have a medical disorder or other condition that, in the opinion of the Investigator or Sponsor, would preclude accurate evaluation or interfere with participation in the study.

Mujeres embarazadas o en periodo de lactancia en el día 0 o que pretendan quedarse embarazadas durante el estudio.
Mujeres que padecen una enfermedad o trastorno (p. ej., diabetes, una enfermedad por inmunodeficiencia [como la infección por el virus de la inmunodeficiencia humana (VIH)]) que las predisponga a una infección fúngica recidivante.
Pacientes con una afección ginecológica que contraindique el uso de óvulos o cremas vaginales.
Pacientes en tratamiento actual con inmunodepresores o corticosteroides.
Pacientes que hayan usado tratamiento antibiótico intravaginal o sistémico en los 14 días previos al día 0.
Pacientes que hayan usado tratamiento antifúngico intravaginal o sistémico en los 7 días anteriores al día 0.
Pacientes con otras causas infecciosas de vaginitis (p. ej., Trichomonas vaginalis [o cualquier otro protozoo], Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simple o virus del papiloma humano [VPH]) confirmadas mediante el kit para el test de vaginitis FemLab®, un test de diagnóstico rápido que se realizará en la selección.
Pacientes con otra afección vaginal o vulvar que confundiría la interpretación de la respuesta clínica.Pacientes que presenten alguna hemorragia vaginal.
Pacientes que prevean tener la menstruación durante el periodo de tratamiento del estudio (es decir, en los próximos 10 días)
Pacientes que tengan que recibir tratamiento médico o quirúrgico durante el estudio por neoplasia intraepitelial cervical (NIC) o carcinoma cervical.
Pacientes que reciban tratamiento anticoagulante (p. ej., cumadina, warfarina) durante las cuatro semanas anteriores al día 0, a excepción de aspirina en dosis baja (como máximo 100 mg/día) como profilaxis cardiovascular.
Pacientes con alergia o sensibilidad a alguno de los fármacos del estudio, componentes o derivados de los excipientes de la formulación, a medicamentos químicamente similares o a los aditivos de la formulación.
Pacientes que hayan tomado disulfiram en los 14 días anteriores al día 0.
Pacientes que hayan usado alguna sustancia en investigación en los 30 días previos al día 0.
Pacientes con un trastorno médico u otra enfermedad que, en opinión del investigador o del promotor, impediría la correcta evaluación o interferiría con la participación en el estudio

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is the Therapeutic Cure, defined as the subject achieving all 3 cures, i.e., Clinical, Mycological, and Bacterial Cures

El criterio principal de valoración de la eficacia es la curación terapéutica, definida como la paciente que logra las 3 curaciones, es decir, clínica, micológica, y bacteriana

E.5.1.1

Timepoint(s) of evaluation of this end point

At visit 2 (end of study / test of cure [FdE / TOC] days 21 to 30).

En la visita 2 (fin del estudio/prueba de curación [FdE/TOC]; días 21 a 30).

E.5.2

Secondary end point(s)

Scored the severity of clinical signs and symptoms reported by the patient, itching, vaginal discharge (eg., Color, odor, amount), irritation, itching, edema, dyspareunia, and dysuria

Se puntuará la intensidad de los signos y síntomas clínicos referidos por la paciente, como prurito, leucorrea (p. ej., color, olor, cantidad), irritación, escozor, edema, dispareunia, y disuria

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 0, days 4 to 6, days 11 to 13 and days 21 to 30

Día 0, Días 4 a 6, Días 11 a 13 y Días 21 a 30

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)

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

crema vaginal de metronidazol (500 mg) y nistatina (100.000 UI)

vaginal cream of metronidazol (500 mg) and nystatin (100.000 UI)

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

The end of the trial is expected to be in December 2011

El final de este ensayo se prevé para Diciembre de 2011

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:

184

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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

184

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)

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

2011-12-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-09-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-08-31

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