Clinical Trials Register

Summary
EudraCT Number:	2014-000996-18
Sponsor's Protocol Code Number:	FJQ-BUP-2014-01
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:	2015-02-16
Trial 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

2014-000996-18

A.3

Full title of the trial

CLINICAL TRIAL TO EVALUATE THE EFFICACY AND THE SECURITY OF DEXAMETASONE+BUPIBACAINE+ARTICAINE+EPINEFRINE “VERSUS” ARTICAINE+EPINEFRINE IN THE POSTQUIRURGICAL PAIN OF THIRD MOLAR SURGERY

ENSAYO CLÍNICO PARA EVALUAR LA EFICACIA Y LA
SEGURIDAD DE DEXAMETASONA+BUPIVACAÍNA+ARTICAINAEPINEFRINA
VERSUS ARTICAINA+EPINEFRINA EN EL DOLOR
POSTOPERATORIO DE LA CIRUGÍA DEL TERCER MOLAR

A.3.1

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

TO EVALUATE THE EFFECT THAT PRODUCE THE MIX OF DEXAMETASONE+BUPIVACAINE+ARTICAINE+EPINEFRINE IN THE COMFORT OF POSTQUIRURGICAL PAIN AFTER THE THIRD MOLAR REMOVING.

Evaluar el efecto que produce la mezcla de dexametasona+bupivacaina+articaina-epinefrina frente a articaina-epinefrina en el alivio de dolor posoperatorio tras la extracción del tercer molar.

A.3.2

Name or abbreviated title of the trial where available

FJQ-BUP-2014-01

A.4.1

Sponsor's protocol code number

FJQ-BUP-2014-01

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	Complejo Hospitalario Torrecárdenas
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Complejo Hospitalario Torrecárdenas
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	FIBAO
B.5.2	Functional name of contact point	FIBAO
B.5.3	Address:
B.5.3.1	Street Address	C/ Hermandad de Donantes S/N
B.5.3.2	Town/ city	Almeria
B.5.3.3	Post code	04009
B.5.3.4	Country	Spain
B.5.4	Telephone number	950016901
B.5.6	E-mail	jgalvan@fibao.es

D. IMP Identification
D.IMP: 1
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	Articaina-epinefrina
D.2.1.1.2	Name of the Marketing Authorisation holder	Normon 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	Articaina-Epinefrina
D.3.2	Product code	Ultracain
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Dental use Intralesional 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	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	Dexametasona
D.2.1.1.2	Name of the Marketing Authorisation holder	KERN PHARMA
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	Dexametasona
D.3.2	Product code	Dexametasona KERN PHARMA
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Dental use Intralesional 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: 3
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	Bupivacaina
D.2.1.1.2	Name of the Marketing Authorisation holder	BRAUN
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	BUPIVACAINA
D.3.2	Product code	BUPIVACAINA-BRAUN
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Dental use Intralesional 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

THIRD MOLAR REMOVING

Extracción del tercer molar

E.1.1.1

Medical condition in easily understood language

THIRD MOLAR REMOVING

Extracción del tercer molar

E.1.1.2

Therapeutic area

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

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

TO EVALUATE THE EFFECT AND THE SECURITY OF ARTICAINE-EPINEFRINE, BIPIVACAINE+DEXAMETASONE( THOSE LAST ONE ASSOCIATES ) AGAINST ARTICAINE-EPINEFRINE IN THE CONTROL OF POSTQUIRURGICAL PAIN AFTER THE INFERIOR THIRD MOLAR SURGERY

Evaluar la eficacia y seguridad de articaina-epinefrina,
bupivacaina+dexametasona (estos dos últimos asociados) frente a articainaepinefrina
en el control del dolor postoperatorio tras la cirugía de los terceros
molares inferiores.

E.2.2

Secondary objectives of the trial

NOT APPLICABLE

No procede

E.2.3

Trial contains a sub-study

E.2.3.1

Full title, date and version of each sub-study and their related objectives

NO PROCEDE

E.3

Principal inclusion criteria

1. ADULT PATIENTS BETWEEN 18-45 YEARS OLD, AGE RANGE IN THAT USUALLY , THE THIRD MOLAR EMERGE OR PRODUCE THE DIFFERENT PÀTOLOGIES DERIVATES OF INCOMPLETE OR NOT ,EMERGING OF THIS ONE.
2. MEN AND WOMEN WIL BE SELECTED.
3 ONLY ONE PROCEDURE BY ONLY ONE SURGICAL ACT, I.E.,ONLY ONE EXTRACTION FOR EACH PATIENT AND INCIDENT.
4 PROCEDURE DONE UNDER LOCAL ANESTHESIA.
5 PATIENTS WHO HAVE AUTHORIZED THIRD REMOVING, SIGNING THE PATIENT INFORMATION FORM.

1. Pacientes adultos de entre 18-45 años, rango de edad en el que generalmente se
produce la erupción o las diferentes patologías derivadas de la incompleta o falta de
erupción.
2. Serán seleccionados tanto hombres como mujeres.
3. Procedimiento único por acto quirúrgico, es decir, sólo una extracción por paciente y
episodio.
4. Procedimiento realizado bajo anestesia local
5. Pacientes que han autorizado su extracción con la firma el Consentimiento
Informado.

E.4

Principal exclusion criteria

1.PATIENTS UNDER 18 OR HIGHER 46 YEARS OLD.
2. MULTIPLE PROCEDURE, I.E., MORE THAN ONE EXTRACTION IN THE SAME SURGICAL ACT.
3 ANTICOAGULATED PATIENTS.
4. PATIENTS UNDER ONCOLOGICAL TREATMENT.
5. PATIENTS UNDER BISPHOSPHONATES TREATMENT
6. PATIENTS WTITH SISTEMIC PATHOLOGY THAT SHOULD BE PRODUCED INTERFERENCES WITH THE RESULT.
7. THIRD MOLAR WITH ODONTOGENIC CYST ASSOCIATES.
8. PATIENTS WHO HAVE RECIVIED LOCOREGIONAL RADIOTHERAPIC TREATMENT
9. PREVIOUS SURGERY IN THE INFERIOR RETROMOLAR TRIANGULE.
10 MENTAL DISSABILITY PATIENTS
11. PATIENETSWHO HAVE BEEN OPERATED UNDER GENERAL ANESTHESIA OR SEDATTION.
12. PRESENCE OF ACTIVE DISCHARGE INFECTION IN THE TIME OF SURGERY

13 PATIENTS WITH ALLERGIES AND/OR INTOLERANCE TO THE DRUGS THAT THIS STUDY USES.

14. PATIENTS WHO HAVE ALLERGIES TO BETALACTAMICS OR NSAID.
15. PREGNANT WOMEN OR WITH POSSIBILITY ( CHECKED WITH PREGNANT TEST)
16. PATIENTS WHO DON´T WANT, AUTHORIZE TO ENJOY IN THE STUDY OR NOT UNTHERSTAND THE SPANISH LANGUAGE.
17 ANY MEDICAL OR SURGICAL CONDITION THAT , UNDER THE RESEARCHER JUDGMENT, PUTS THE PATIENT UNDER DANGER SITUATION OR TO PREVENT THE PATIENT DON´T MEET THE REQUERIMENTS OR FINISH THE STUDY.

1. Paciente menores de18 años o mayor de 46 años
2. Procedimiento múltiple, es decir, poliextracción dental en el mismo acto quirúrgico.
3. Pacientes anticoagulados.
4. Pacientes en tratamiento oncológico.
5. Pacientes en tratamiento con bifosfonatos.
6. Paciente con patología sistémica que pueda interferir en el resultado.
7. Cordales que presenten quistes odontogéncios asociados.
8. Pacientes que hayan recibido radioterapia locorregional.
9. Cirugía previa en zona de trígono retromolar inferior.
10. Pacientes discapacitados.
11. Pacientes intervenidos bajo anestesia general y/o sedación.
12. Presencia de infección activa supurativa en el momento de la cirugía.
13. Pacientes con alergias y/o intolerancias a los fármacos a utilizar en este estudio
14. Pacientes con alergia a antibióticos Betalactámicos o AINE.
15. Pacientes embarazadas o posibilidad de embarazo (comprobado por test de
gestación).
16. Paciente que no desee ni autorice participar en el estudio o no dominen o
comprendan de forma correcta el idioma español.
17. Cualquier condición médica o quirúrgica que a criterio del investigador, ponga al
paciente en una situación de riesgo o que impida que el paciente cumpla los requisitos
del estudio o finalice el mismo.

E.5 End points

E.5.1

Primary end point(s)

E.5.1.1

Timepoint(s) of evaluation of this end point

24 HOURS

24 horas

E.5.2

Secondary end point(s)

NOT APPLICABLE

No procede

E.5.2.1

Timepoint(s) of evaluation of this end point

NOT APPLICABLE

No procede

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

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

Yes

E.8.4

The trial involves multiple sites in the 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

WHEN THE LAST PATIENT HAS BEEN FINISHED OF EVALUATING, SPECIFICALLY , ONE WEEK LATER OF THE LAST PATIENT HAS BEEN INCLUDED.

Cuando terminado de evaluar el último paciente, concretamente, a la semana de haber incluido el último paciente.

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

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-02-16.

Yes

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

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)

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

2015-04-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-02-16

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

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