Clinical Trials Register

Summary
EudraCT Number:	2013-003323-11
Sponsor's Protocol Code Number:	ITIBU001
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2014-02-04
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2013-003323-11

A.3

Full title of the trial

RANDOMIZED CLINICAL TRIAL, PLACEBO-CONTROLLED, SPLIT-MOUTH, A
DOUBLE-BLIND, FOR THE EVALUATION OF THE EFFECTIVENESS OF PREemptive
ANALGESIA BY ADMINISTRATION OF IBUPROFEN 400MG, FOR THE
CONTROL OF POSTOPERATIVE ACUTE PAIN in the extraction of IMPACTED
THIRD MOLAR MANDIBULAR

TRIAL CLINICO RANDOMIZZATO, PLACEBO-CONTROLLATO, SPLIT-MOUTH,
A DOPPIO CIECO, PER LA VALUTAZIONE DELL'EFFICACIA DELLA PREEMPTIVE
ANALGESIA MEDIANTE SOMMINISTRAZIONE PER OS DI
IBUPROFENE 400MG, SUL CONTROLLO DEL DOLORE ACUTO POSTOPERATORIO
NELL'ESTRAZIONE DEL TERZO MOLARE MANDIBOLARE
INCLUSO

A.3.1

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

EVALUATION OF THE EFFECTIVENESS OF PRE-emptive ANALGESIA BY
ADMINISTRATION OF IBUPROFEN 400MG, FOR THE CONTROL OF
POSTOPERATIVE ACUTE PAIN in the extraction of IMPACTED THIRD MOLAR
MANDIBULAR

VALUTAZIONE DELL'EFFICACIA DELLA PRE-EMPTIVE ANALGESIA
MEDIANTE SOMMINISTRAZIONE PER OS DI IBUPROFENE 400MG, SUL
CONTROLLO DEL DOLORE ACUTO POST-OPERATORIO NELL'ESTRAZIONE
DEL TERZO MOLARE MANDIBOLARE INCLUSO.

A.3.2

Name or abbreviated title of the trial where available

PRE-EMPTIVE ANALGESIA

A.4.1

Sponsor's protocol code number

ITIBU001

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	"Sapienza" University of Rome
B.1.3.4	Country	Italy
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	"SAPIENZA" UNIVERSITY OF ROME
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	"SAPIENZA" UNIVERSITY OF ROME
B.5.2	Functional name of contact point	DEPT. OF ORAL AND MAXILLO FACIAL SC
B.5.3	Address:
B.5.3.1	Street Address	VIA CASERTA, 6
B.5.3.2	Town/ city	ROME
B.5.3.3	Post code	00161
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390649976651
B.5.5	Fax number	00390644230811
B.5.6	E-mail	susanna.annibali@uniroma1.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	Yes
D.2.1.1.1	Trade name	BRUFEN 400 MG
D.2.1.1.2	Name of the Marketing Authorisation holder	ABBOTT Srl
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	BRUFEN 400MG
D.3.4	Pharmaceutical form	Capsule, hard
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

POST-OPERATIVE ACUTE PAIN (DAPO)

DOLORE ACUTO POST-OPERATORIO

E.1.1.1

Medical condition in easily understood language

POST-OPERATIVE ACUTE PAIN (DAPO)

DOLORE ACUTO POST-OPERATORIO

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	17.1
E.1.2	Level	PT
E.1.2	Classification code	10031009
E.1.2	Term	Oral pain
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.1
E.1.2	Level	PT
E.1.2	Classification code	10030973
E.1.2	Term	Oral discomfort
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The aim of this study was to evaluate the analgesic effect of ibuprofen in
patients undergoing surgical extraction of mandibular third molars
included.

Scopo dello studio è valutare l'effetto analgesico della somministrazione
preventiva di ibuprofene nei pazienti sottoposti ad estrazione chirurgica
dei terzi molari mandibolari inclusi.

E.2.2

Secondary objectives of the trial

Objective 1: decrease in the intensity of Acute Post-operative Pain (DAPO) within 3 days after surgery, assessed using a numerical scale (Numeral Rating Scale-11, NRS-11), presented graphically as a vertical column of 100 mm from the bottom-oriented upwards, divided into 11 equal squares with numbers from 0 to 10. Both ends of the scale are defined by "no pain" to "worst pain imaginable."
 Objective 2: postoperative decrease in the consumption of the same drug measured in number of tablets taken within 7 days following surgery.

Obiettivo 1 : diminuzione dell’intensità del Dolore Acuto Post-operatorio (DAPO) nei 3 giorni successivi all’intervento, valutato utilizzando una scala numerica (Numeral Rating Scale-11, NRS-11), presentata graficamente come una colonna verticale di 100 mm orientata dal basso verso l’alto, divisa in 11 caselle uguali con numeri da 0 a 10. Le due estremità della scala sono definite da “nessun dolore” fino a “massimo dolore immaginabile”.
 Obiettivo 2: diminuzione del consumo post-operatorio dello stesso farmaco valutato in numero di compresse assunte nei 7 giorni seguenti all’intervento chirurgico.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

males and females aged between 18 and 40 years, absence of systemic
disease (ASA class I), non-smoking or smoking <10 cigarettes / day;
plaque index and bleeding less than 25%, indicating to extract both
lower wisdom teeth inclusion in partial or total bilateral bone
(osteotomy applicant), similar in depth, inclination and position, no
medication in the 10 days prior to the extraction, presence in the arch of
the first and second molars, absence of pain and associated osteolytic
disease.

soggetti maschi e femmine di età compresa tra i 18 e 40 anni; assenza
dipatologie sistemiche (classe ASA I); non fumatori o fumatori <10
sigarette/die; indice di placca e di sanguinamento inferiore al 25%;
indicazione a estrarre entrambi i denti del giudizio inferiori in inclusione
ossea parziale o totale bilaterale (richiedente osteotomia), simili per
profondità, inclinazione e posizione; nessuna assunzione di farmaci nei
10 giorni precedenti l'estrazione; presenza in arcata del primo e del
secondo molare; assenza di sintomatologia dolorosa e patologie
osteolitiche associate.

E.4

Principal exclusion criteria

Exclusion criteria will be: persons under age or older than 40 years old; subjects with systemic diseases; Smoking <10 cigarettes / day; plaque index and bleeding than 25%; individuals with anatomical differences between the lower wisdom teeth inclusion in partial or total bilateral bone (osteotomy applicant), with respect to the depth, the 'tilt and position; subjects who took drugs in the 10 days prior to extraction; absence in the arch of the first and second molar; the presence of lytic bone disease and pain symptoms associated with items to be extracted.

I criteri di esclusione saranno: soggetti minorenni o con età superiore ai 40 anni; soggetti che presentano patologie sistemiche ; fumatori < 10 sigarette/die; indice di placca e di sanguinamento superiore al 25%; soggetti che presentano differenze anatomiche tra i denti del giudizio inferiori in inclusione ossea parziale o totale bilaterale (richiedente osteotomia), per quanto riguarda la profondità, l’ inclinazione e la posizione; soggetti che hanno assunto farmaci nei 10 giorni precedenti l’estrazione; assenza in arcata del primo e del secondo molare; presenza di sintomatologia dolorosa e patologie osteolitiche associate agli elementi da estrarre.

E.5 End points

E.5.1

Primary end point(s)

REGISTRATION pain intensity at fixed times (8:00-13:00-18:00-23:00),
so as to obtain the "curve of pain"; For the evaluation of the degree of
pain, will be used for both diaries a numerical scale (Numeral Rating
Scale-11, NRS-11), presented graphically as a vertical column of 100
mmoriented from bottom to top, divided into 11 equal squares with
numbersfrom 0 to 10. The two ends of the scale were defined as "no
pain" to "worst pain imaginable."

REGISTRAZIONE DELl'intensità del dolore in corrispondenza di orari
prestabiliti (8:00-13:00-18:00-23:00), in modo da ottenere la "curva del
dolore"; Per la valutazione del grado di dolore, verrà utilizzata per
entrambi i diari una scala numerica (Numeral Rating Scale-11, NRS-11),presentata graficamente come una colonna verticale di 100 mm
orientata dal basso verso l'alto, divisa in 11 caselle uguali con numeri da 0 a 10. Le due estremità della scala sono state definite da "nessun
dolore" fino a "massimo dolore immaginabile".

E.5.1.1

Timepoint(s) of evaluation of this end point

7 DAYS

7 GIORNI

E.5.2

Secondary end point(s)

intake of a possible compressed support (rescue therapy) and the
intensity of the pain associated.

assunzione di un'eventuale compressa di supporto (rescue therapy) e
l'intensità del dolore associato.

E.5.2.1

Timepoint(s) of evaluation of this end point

7 DAYS

7 GIORNI

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

E.6.4

Safety

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

E.8.1.6

Cross over

Yes

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

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

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

NESSUNO

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

2014-10-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-09-12

P. End of Trial
P.	End of Trial Status	Ongoing

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