Clinical Trials Register

Summary
EudraCT Number:	2016-003658-34
Sponsor's Protocol Code Number:	9732
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:
Date on which this record was first entered in the EudraCT database:	2017-01-10
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

France - ANSM

A.2

EudraCT number

2016-003658-34

A.3

Full title of the trial

Non-inferiority of intranasal fentanyl versus oral morphine sulfate in the treatment of pain in pediatric trauma : a controled randomized , single blind study

Etude randomisée contrôlée en simple aveugle évaluant la non infériorité du Fentanyl intranasal versus sulfate de morphine per os dans le traitement de la douleur en traumatologie pédiatrique

A.3.1

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

intranasal fentanyl versus oral morphine sulfate in the treatment of pain in pediatric trauma

Evaluation du Fentanyl intranasal versus sulfate de morphine per os dans le traitement de la douleur en traumatologie pédiatrique

A.3.2

Name or abbreviated title of the trial where available

FINDOL

A.4.1

Sponsor's protocol code number

9732

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	University Hospital of Montpellier
B.1.3.4	Country	France
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	University of Montpellier
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	Research Department of Montpellier Hospital
B.5.2	Functional name of contact point	Research Department _ sponsor Unit
B.5.3	Address:
B.5.3.1	Street Address	Hopital La Colombiere, 39 avenue C. Flahault
B.5.3.2	Town/ city	Montpellier
B.5.3.3	Post code	34295
B.5.3.4	Country	France
B.5.4	Telephone number	0033467330924
B.5.5	Fax number	0033467339172
B.5.6	E-mail	c-chauveton@chu-montpellier.fr

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	Oramorph
D.2.1.1.2	Name of the Marketing Authorisation holder	L. Molteni and C.Dei
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.3.1	Product name	sulfate de morphine
D.3.4	Pharmaceutical form	Oral solution
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	MORPHINE SULFATE
D.3.9.4	EV Substance Code	SUB14597MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30/5
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	Fentanyl
D.2.1.1.2	Name of the Marketing Authorisation holder	Mylan
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.3.1	Product name	Fentanyl
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intranasal use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	FENTANYL
D.3.9.4	EV Substance Code	SUB07597MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500/10
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	Solution for injection
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

traumatic pain

douleur traumatique

E.1.1.1

Medical condition in easily understood language

pain

douleur

E.1.1.2

Therapeutic area

Diseases [C] - Symptoms and general pathology [C23]

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 assess the non inferiority of a treatment by Fentanyl intranasal vs morphin sulfate (oral use) in children suffering from traumatic pain

Evaluer la non infériorité du fentanyl intranasal au sulfate de morphine per os dans le traitement de la douleur chez l’enfant dans un contexte traumatique.

E.2.2

Secondary objectives of the trial

to assess :
Tolerability
Feasability of the administation of the treatment
onset of treatments efficacity

Evaluer et comparer la tolérance aux traitements , la faisabilité de mise en oeuvre, et comparer le début d’action des deux antalgiques.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Patient aged between 4 years old and 15,3 years old

-Acute pain in traumatic context with a suspicion of fracture
for patient <7years old : feeling Pain>6/10 defined with a face analogue scale and a visual analogic scale (the difference between the scales is not <10 oints)
- For patients >7 years old : feeling pain >6 points and defined thanks to a visual analogic scale
-Informed consent form signed by parents
- Beneficiary of an european health protection

Age : Enfants de 4 ans à 15 ans et 3 mois
Douleur aiguë dans un contexte traumatique avec suspicion de fracture (déformation)
Evaluation de la douleur ≥ 6/10, par l’échelle des visages et l’EVA, si âge entre 4 à 7 ans ou l’EVA seule si âge ≥ 7 ans
Cohérence des valeurs données par les deux échelles chez les enfants de 4 à 7 ans (écart maximal de +/-10 points entre les deux échelles)
Consentement des parents ou du tuteur légal et de l’enfant
Obligation d'affiliation ou bénéficiaire d'un régime de sécurité sociale européen

E.4

Principal exclusion criteria

Antalgic ( II or III) within 4 hours before the inclusion
Allergic or non-indication of fentanyl
Allergic or contraindication of morphine sulfate
pre Existing peripheral intravenous catheter
Traumatic brain injury
nasal traumatic

Analgésie par antalgique de pallier II ou III dans les 4 heures précédant l'arrivée aux urgences
Allergie ou contre-indication au fentanyl
Allergie ou contre-indication au sulfate de morphine
Refus ou difficulté de compréhension du protocole par les détenteurs de l'autorité parentale, ou absence de tuteurs légaux
Voie IV pré-existante
Traumatisme crânien de gravité modérée à sévère
Traumatisme nasal

E.5 End points

E.5.1

Primary end point(s)

Passessment of the pain feeling defined by Visual analogic scale (face scale and analogic scale)

Diminution de la douleur évaluée par des échelles standardisées (EVA et échelle des visages) à T45.

E.5.1.1

Timepoint(s) of evaluation of this end point

45 minutes

E.5.2

Secondary end point(s)

1.Onset of treatment efficacity
2.treatment failure
3.Adverse events

1. Evaluation du début de l’action antalgique des deux traitements
2. Evaluation du taux d’échec des deux traitements
3. Recensement des effets secondaires par observation clinique et monitoring

E.5.2.1

Timepoint(s) of evaluation of this end point

1. up to 45 minutes
2. Up to 1 hour
3. up to 48 hours

-Jusqu'à 45 minutes
-Jusqu'à 1heure
- jusqu'à 48 heures

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

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

Yes

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

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

Yes

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

date of the database

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 months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

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)

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

2016-12-26

Ethics Committee Opinion of the trial application

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status

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