Clinical Trials Register

Summary
EudraCT Number:	2014-001300-22
Sponsor's Protocol Code Number:	PHRCI/2013/MV-001
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2015-06-26
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

2014-001300-22

A.3

Full title of the trial

Evaluation de trois types d’infiltrations dans le cadre du traitement des épicondylalgies latérales : Leukocyte – Platelet Rich Plasma (L-PRP) versus Toxine botulique de type A (Xeomin®, MERZ) versus Glucocorticoïdes – Essai thérapeutique multicentrique contrôlé randomisé en double aveugle à trois bras parallèles

A.3.1

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

Evaluation de trois types d’infiltrations dans le cadre du traitement des épicondylalgies latérales : PRP/Glucocorticoides/tocine botulique A

A.3.2

Name or abbreviated title of the trial where available

LET

A.4.1

Sponsor's protocol code number

PHRCI/2013/MV-001

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	CHU de Nîmes
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	DGOS
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	CHU de Nîmes
B.5.2	Functional name of contact point	Brigitte LAFONT
B.5.3	Address:
B.5.3.1	Street Address	Place du Pr Debré
B.5.3.2	Town/ city	Nîmes
B.5.3.3	Post code	30019
B.5.3.4	Country	France
B.5.4	Telephone number	33466686715
B.5.5	Fax number	33466683400
B.5.6	E-mail	brigitte.lafont@chu-nimes.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	Xeomin
D.2.1.1.2	Name of the Marketing Authorisation holder	MERZ PHARMACEUTICALS GMBH
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	XEOMIN 50 Unités
D.3.4	Pharmaceutical form	Powder for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular and intravenous use (Noncurrent) Intramuscular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	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	ALTIM
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS FRANCE
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	ALTIM 3.75 mg/1.5ml
D.3.4	Pharmaceutical form	Suspension for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Periarticular 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

epicondylitis

épicondylalgies

E.1.1.1

Medical condition in easily understood language

Tennis elbow

tennis elbow

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	PT
E.1.2	Classification code	10014971
E.1.2	Term	Epicondylitis
E.1.2	System Organ Class	10022117 - Injury, poisoning and procedural complications

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

L’objectif principal de l’étude est de comparer le profil d’évolution de la douleur moyenne sur les 24 dernières heures (mesurée par une EVA) entre J0 et 6 mois post-infiltration entre les trois groupes.

E.2.2

Secondary objectives of the trial

A- L’efficacité globale du traitement définie par une diminution d’au minimum de 25% de la douleur moyenne sur les 24 dernières heures entre J0 et 6 mois.
B- L’évolution de la douleur moyenne sur les 24 dernières heures entre J0 et chacun des différents temps (3 semaines, 6 semaines, 3 mois et 6 mois).
C- L’évolution de la douleur maximale, de l’EVA nocturne et de l’EVA à l’effort (test au grip de Jamar) entre J0, 3 semaines, 6 semaines, 3 mois et 6 mois.
D- La perception au changement sur le Patient’s Global Impression of change (PGIC) à 3 et 6 mois
E- L’évolution du score PRTEE entre 0, 3 mois et 6 mois
F- Les effets secondaires à 3 semaines, 6 semaines, 3 mois et à 6 mois.

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

E.3

Principal inclusion criteria

Critères d’inclusion généraux :
• Le patient doit avoir donné son consentement libre et éclairé et signé le consentement
• Le patient doit être affilié ou bénéficiaire à un régime d’assurance maladie
• Le patient est disponible pour un suivi de 6 mois
• Les femmes et les hommes sont inclus(es)
• Le patient est âgé d’au moins 18 ans
Critères d’inclusion concernant la population cible : le patient présente une épicondylalgie latérale objectivée par :
• Clinique : symptômes évoluant depuis plus de 6 semaines et moins de 12 mois. La liste des symptômes devant être présents est : douleur à la palpation de l’épicondyle latérale, douleur à la contraction contrariée des épicondyliens latéraux.
• Thérapeutique : moins de deux infiltrations de corticostéroïdes réalisées dont la dernière datant de plus de 3 mois.

E.4

Principal exclusion criteria

Critères de non-inclusion généraux :
• Le patient participe à une autre étude
• Le patient est en période d’exclusion déterminée par une étude précédente
• Le patient est sous sauvegarde de justice
• Le patient est sous tutelle ou sous curatelle
• Le patient refuse de signer le consentement
• Il s’avère impossible de donner au sujet des informations éclairées
Critères de non-inclusion concernant les maladies ou conditions associé(e)s interférent(e)s :
• La patiente est enceinte, parturiente ou elle allaite
• Le patient présente une allergie à la toxine botulique de type A et/ou aux glucocorticoïdes
• Le patient présente une épicondylalgie médiale
• Le patient présente des antécédents de chirurgie de coude
• Le patient présente une des pathologies suivantes : immunodépression, maladie rhumatismale, hépatite, diabète, autre pathologie du membre homolatéral, trouble neurologique (radiculopathie, compression du nerf radial)
• Le patient a bénéficié d’un traitement aux corticostéroïdes dans les 3 derniers mois

E.5 End points

E.5.1

Primary end point(s)

Objectifs Principal, A, B, C : Douleur (EVA moyenne sur les 24 dernières heures, EVA maximale et EVA nocturne) : de 0 à 10

E.5.1.1

Timepoint(s) of evaluation of this end point

l'Objectif Principalest évalué à J0, 3S, 6S, 3M, 6M

E.5.2

Secondary end point(s)

Obje tif A : Efficacité globale en %
Objectif C : Douleur après évaluation du grip au Jamar (EVA) : de 0 à 10
Objectif E : Evaluation fonctionnelle (Score PRTEE) : de 0 à 100
Objectif D : PGIC (Patients Global Impression of Change) : de 1 à 7
Objectif F : Recueil des effets secondaires : Qualitatif
Objectif G : SF36 de 0 à 100

E.5.2.1

Timepoint(s) of evaluation of this end point

Obje tif A : Efficacité globale en % : à J0, 6M
Objectif C : Douleur après évaluation du grip au Jamar (EVA) : à J0, 3M, 6M
Objectif E : Evaluation fonctionnelle (Score PRTEE) : à J0, 3M, 6M
Objectif D : PGIC (Patients Global Impression of Change) : à 3M, 6M
Objectif F : Recueil des effets secondaires : à J0, 3S, 6S, 3M, 6M
Objectif G : SF36 de 0 à 100 : à 3M, 6M

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

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

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

date de gel de la base de données

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:

216

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

216

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

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

2014-12-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-07-18

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

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