Clinical Trials Register

Summary
EudraCT Number:	2014-004682-24
Sponsor's Protocol Code Number:	DC0071BB405
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2015-11-10
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

2014-004682-24

A.3

Full title of the trial

Efficacy of DC071 mouthwash (0,2 % chlorhexidine digluconate) in peri-surgical care for preventing alveolar osteitis after third molar extraction.
Prospective, multicenter, randomised, double-blind, placebo controlled study in parallel groups

Eficacia del enjuague bucal DC071 (clorhexidina digluconato 0,2 %) en el cuidado
pre y postoperatorio para la prevención de la osteítis alveolar tras extracción del
tercer molar.
Estudio prospectivo, multicéntrico, aleatorizado, con doble enmascaramiento,
controlado con placebo en grupos paralelos.

A.3.1

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

Efficacy of DC071 mouthwash (0,2 % chlorhexidine digluconate) in peri-surgical care for preventing alveolar osteitis after third molar extraction.

Eficacia del enjuague bucal DC071 (clorhexidina digluconato 0,2 %) en el cuidado
pre y postoperatorio para la prevención de la osteítis alveolar tras extracción del
tercer molar.

A.4.1

Sponsor's protocol code number

DC0071BB405

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	PIERRE FABRE MEDICAMENT
B.1.3.4	Country	France
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	PIERRE FABRE MEDICAMENT
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	PIERRE FABRE MEDICAMENT
B.5.2	Functional name of contact point	Clinical Trial Information Desk
B.5.3	Address:
B.5.3.1	Street Address	3 avenue Hubert Curien - BP 13562
B.5.3.2	Town/ city	TOULOUSE Cedex 01
B.5.3.3	Post code	31035
B.5.3.4	Country	France
B.5.4	Telephone number	+33(0)534506329
B.5.5	Fax number	+33(0)534503329
B.5.6	E-mail	contact_essais_cliniques@pierre-fabre.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	Yes
D.2.1.1.1	Trade name	clorhexidina digluconato
D.2.1.1.2	Name of the Marketing Authorisation holder	PIERRE FABRE MEDICAMENT
D.2.1.2	Country which granted the Marketing Authorisation	France
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.3.2	Product code	DC071
D.3.4	Pharmaceutical form	Mouthwash
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oromucosal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CHLORHEXIDINE DIGLUCONATE
D.3.9.1	CAS number	18472-51-0
D.3.9.2	Current sponsor code	DC071
D.3.9.3	Other descriptive name	CHLORHEXIDINE DIGLUCONATE SOLUTION
D.3.9.4	EV Substance Code	SUB11810MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.2
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Mouthwash
D.8.4	Route of administration of the placebo	Oromucosal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Prevention of alveolar osteitis after third molar extraction

prevención de la osteítis alveolar tras una extracción del tercer molar.

E.1.1.1

Medical condition in easily understood language

Prevention of alveolar osteitis after third molar extraction

prevención de la osteítis alveolar tras una extracción del tercer molar.

E.1.1.2

Therapeutic area

Diseases [C] - Mouth and tooth diseases [C07]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	PT
E.1.2	Classification code	10066995
E.1.2	Term	Alveolar osteitis
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 demonstrate the efficacy of chlorhexidine mouthwash in the prevention of alveolar osteitis following third molar extraction.

Demostrar la eficacia del enjuague bucal de clorhexidina para la prevención
de la osteítis alveolar tras una extracción del tercer molar.

E.2.2

Secondary objectives of the trial

To evaluate the safety and the local tolerability of DC071.

Evaluar la seguridad y la tolerabilidad local de DC071.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Male or female, over 18 years old
- Subject needing to undergo extraction of one impacted mandibular third molar
- For woman of childbearing potential and for woman in menopausal period under hormonal substitution treatment, she must accept to plan the extraction of the impacted mandibular third molar only during the last week of the menstrual cycle

- Hombre o mujer mayor de 18 años
- Paciente que requiera extracción de un tercer molar mandibular
impactado
- Duración prevista de la cirugía menor a 30 minutos (intervalo de
tiempo entre la incisión y la sutura/hemostasia primaria), con base
en la posición del diente y de las raíces, lo que predice el grado de
dificultad de la extracción quirúrgica
- Limpieza bucal preoperatoria con profilaxis oral realizada antes de
la cirugía (cepillado de dientes rutinario y bien realizado)
- En caso de mujeres con probabilidades de quedar embarazadas así
como en mujeres en periodo postmenopáusico con tratamiento de
sustitución hormonal, la paciente debe aceptar la planeación de la
extracción de su tercer molar mandibular impactado únicamente
durante la última semana del ciclo menstrual

E.4

Principal exclusion criteria

- Existence or history of parotid gland disorders
- Acute or history of recent acute pericoronitis at any tooth
- Extraction of more than 1 third molar in the same surgical procedure
- Subject at high risk of bacterial endocarditis (prosthetic heart valve, history of bacterial endocarditis, congenital cyanogenic heart disease)
- Coagulation or haemostatic disorder or use of anticoagulants
- Hypersensitivity to chlorhexidine or any of the excipients;
- Hypersensitivity to any anesthetic agent;
- Hypersensitivity to corticosteroids, analgesics including opioid drugs used for post-surgery pain relief
- Intake of systemic vasodilator or vasoconstrictor
- Intake of systemic or local (in the mouth) antibiotics within 7 days before Day 1 and/or any pre- or post-operative antibiotic prophylaxis planned to be prescribed during the study;
- Use of any antiseptic mouthwash within 7 days before Day -1
- Regular heavy smokers (more than 20 cigarettes per day)
- Is pregnant or in post-partum period or a nursing mother

- Presencia o historial de trastornos de las glándulas parótidas
- Pericoronitis aguda o antecedentes recientes de pericoronitis aguda
en cualquier diente
- Extracción de más de 1 tercer molar en el mismo procedimiento
quirúrgico
- Sujeto a riesgo elevado de endocarditis bacteriana (válvula cardiaca
protésica, antecedentes de endocarditis bacteriana, enfermedad
cardiaca congénita cianógena)
- Cualquier patología asociada con la mandíbula
- Historial de enfermedad orgánica/psiquiátrica de importancia o de
cirugía que a criterio del investigador, pudiese interferir con la
realización del estudio y/o con la evaluación de los parámetros del
mismo
- Trastorno de la coagulación o de la hemostasia o empleo de
anticoagulantes
- Infección con VIH o cualquier tipo de enfermedad inmunosupresora
- Hipersensibilidad a la clorhexidina o a cualquiera de los excipientes;
- Hipersensibilidad a cualquier anestésico;
- Hipersensibilidad a los corticosteroides, analgésicos incluyendo
opioides empleados en el tratamiento del dolor postquirúrgico
- Administración de un vasodilatador o vasoconstrictor sistémico
- Administración de antibióticos sistémicos o locales (en la boca) 7
días o menos antes del Día 1 y/o cualquier profilaxis pre o
postoperatoria planificada durante el estudio;
- Uso de un enjuague bucal antiséptico 7 días o menos antes del Día -

E.5 End points

E.5.1

Primary end point(s)

Occurence of an alveolar osteitis (dry socket) within the 7 days after the extraction of the impacted mandibular third molar.
Alveolar osteitis will be recorded at Visit 4 (End-of-Study visit).

Presencia de osteítis alveolar (alveolo seco) menos de 7 días tras la
extracción del tercer molar mandibular impactado.
La presencia de osteítis alveolar se registrará en la Visita 4 (Visita de
Finalización del estudio).

E.5.1.1

Timepoint(s) of evaluation of this end point

V4 (D8)

E.5.2

Secondary end point(s)

General tolerance by recording of adverse events recorded at each visit.

Local tolerance assessment by the investigator by mouth examination performed by the investigator at V2 (Inclusion visit), V3 (D1 before surgery) and V4 on a 4-point scale (none, mild, moderate or severe) on erythema, oedema, ulceration.

Subject?s global tolerability performed at V4 on a 4-point rating scale (very well tolerated, well tolerated, rather not tolerated, not tolerated at all).

Overall assessments
Investigator?s overall assessment performed at V4 on a 4-point rating scale (very good, good, moderate, poor)

Subject? satisfaction assessment of tested product performed at V4 on a 6-point rating scale (very satisfied, satisfied, rather satisfied, rather not satisfied, not satisfied, not satisfied at all).

Evaluación de la tolerabilidad local por el investigador hecha a
través de un examen bucal en la V2 (Visita de Inclusión), V3 (D1
antes de la cirugía) y V4 en una escala de 4 puntos (sin síntoma,
síntoma leve, moderado o grave) de la intensidad del eritema, edema o
úlcera.

E.5.2.1

Timepoint(s) of evaluation of this end point

V2(D-7 to D-2), V3 (D1) and V4 (D8)

V2(D-7 to D-2), V3 (D1) y V4 (D8)

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)

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Estonia

Latvia

Lithuania

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:

374

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

414

F.4.2.2

In the whole clinical trial

414

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 Sponsor will not supply the study treatment after the study end since the treatment duration for the condition is covered by the study.

El Promotor no proporcionará la medicación del estudio después de la finalización del mismo ya que la duración de la enfermedad ya está cubierta por el estudio

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

2015-12-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-12-10

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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