Clinical Trials Register

Summary
EudraCT Number:	2017-001249-28
Sponsor's Protocol Code Number:	MU2017/001
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2018-08-02
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

2017-001249-28

A.3

Full title of the trial

Phase III, Single-blinded, placebo-Controlled and randomized Clinical Trial with minimal intervention on the Treatment with Plasma Rich in Growth Factors (PRGF) of Work-site Acute Epicondylitis Resistant to Conservative Treatment

ENSAYO CLÍNICO FASE III CON MÍNIMA INTERVENCIÓN, ALEATORIZADO, CIEGO SIMPLE Y CONTROLADO CON PLACEBO DEL TRATAMIENTO DE LA EPICONDILITIS AGUDA RESISTENTE AL TRATAMIENTO CONSERVADOR EN ÁMBITO LABORAL CON PLASMA RICO EN FACTORES DE CRECIMIENTO (PRGF)

A.3.1

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

Clinical trial to determine whether the use of blood growth factors in patients with epicondylitis (tennis elbow) at workplace resistant to conservative treatment is better than infiltration with corticoids or the enlargement of the conservative treatment.

Ensayo clínico para determinar si el tratamiento con factores sanguíneos de crecimiento en pacientes con epicondilitis (codo del tenista) adquirida en ambiente laboral es mejor que la infiltración con corticoides o el alargamiento del tratamiento conservador.

A.3.2

Name or abbreviated title of the trial where available

EPILAB

A.4.1

Sponsor's protocol code number

MU2017/001

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	Mutua Universal MUGENAT
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	Mutua Universal MUGENAT
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	IMIM Hospital del Mar
B.5.2	Functional name of contact point	Jaume Marrugat
B.5.3	Address:
B.5.3.1	Street Address	Dr. Aiguader, 88
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08003
B.5.3.4	Country	Spain
B.5.4	Telephone number	34933160773
B.5.5	Fax number	34933160796
B.5.6	E-mail	jmarrugat@imim.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	Celestone Cronodose
D.2.1.1.2	Name of the Marketing Authorisation holder	Merk Sharp And Dohme
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.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Infiltration Periosseous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Corticoides
D.3.9.3	Other descriptive name	BETAMETHASONE ACETATE
D.3.9.4	EV Substance Code	SUB00780MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5.4
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	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	Mepivacaine
D.2.1.1.2	Name of the Marketing Authorisation holder	INIBSA Hospital
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.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Infiltration
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MEPIVACAINE
D.3.9.1	CAS number	96-88-8
D.3.9.3	Other descriptive name	MEPIVACAINE CHLORIHADRATE
D.3.9.4	EV Substance Code	SUB14514MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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	No
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	PRP
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Periodontal use Infiltration
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PRGF-ENDORET
D.3.9.2	Current sponsor code	MUTUA UNIVERSAL (MUGENAT)
D.3.9.3	Other descriptive name	AUTOLOGOUS PLASMA
D.3.9.4	EV Substance Code	SUB117286
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5 to 15
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	Yes
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	Injection
D.8.4	Route of administration of the placebo	Infiltration

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Epicondylitis

Epicondilitis

E.1.1.1

Medical condition in easily understood language

Tennis elbow

Codo del tenista

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	20.0
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

Primary Objective: To determine whether using autologous conditioned platelet-rich plasma with growth factor is more efficacious than betametasone or physiologic serum infiltration in patients refractory o conservative treatment with anti-inflammatory drugs and rehabilitation.

Objetivo primario: Determinar si el uso terapéutico de las infiltraciones con PRGF es mejor que la infiltración con betametasona o suero fisiológico en los casos refractarios al tratamiento con fármacos antiinflamatorios y rehabilitación.

E.2.2

Secondary objectives of the trial

Secondary Objective: to establish a standardized rehabilitation protocol to address epicondylitis at workplace in patients refractory to basic initial treatment with anti-inflammatory drugs.

Objetivo secundario: Establecer la tasa de éxito de un protocolo estandarizado de abordaje rehabilitador de la epicondilitis en el medio laboral en pacientes resistentes al tratamiento con antiinflamatorios no esteroideos.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Screening phase
a. Men and women older than 18 years
b. Patients with new-onset workplace-acquired epicondylitis clinical diagnosis
c. First presentation (within 30 days of symptom.-onset), and no previous treatment
d. Requiring work-leave

2. Clinical trial phase
a. Patients refractory to 7-day treatment with oral antiinflammatory drugs (Dexketoprofeno,
Enantyum®, 25 mg 1 TID with meals) 7 days (protocol Annex IV), and to an extended 3-week
treatment with standardized physiotherapy (protocol Annex X).
b. Patients who provide informed consent to participate in the study (protocol Annex V).
c. Patients who reside in the areas where Mutua Universal has a centre with biomechanics and a
qualified traumatologist (see protocol section 1.5).

1. Para las fases de cribado
a. Hombres y mujeres trabajadores mayores de 18 años
b. Tener una exploración física inicial compatible con el diagnóstico clínico de epicondilitis adquirida
en medio laboral.
c. Que sea el primer episodio de la sintomatología (menos de 30 días) de forma que no hayan
recibido ningún tratamiento previamente por la misma clínica.
d. Que requiera baja laboral.

2. Para la fase de ensayo clínico:
a. Pacientes que no respondan a un primer tratamiento inicial médico con antiinflamatorios vía oral
(Dexketoprofeno, Enantyum®, 25 mg 1 comprimido cada 8 horas vía oral con las comidas)
durante 7 días (protocolo Anexo IV), y que además no respondan a un protocolo estandarizado
de rehabilitación de tres semanas (protocolo Anexo X).
b. Que firmen el consentimiento informado para participar en el ensayo clínico (protocolo Anexo V).
c. Residentes en zonas en que Mutua Universal tiene centro proveedor de Biomecánica y
Traumatólogo titulado (Ver apartado protocolo 1.5).

E.4

Principal exclusion criteria

1. Patients with diabetes or allergies to study treatments.
2. Patients with relapsing epicondylitis .
3. Patients with chronic epicondylitis of more than 30 days.
4. Patients unwilling to sign an informed consent to participate.
5. Patients with severe diseases with life expectancy shorter than 1 year or whose treatment might
interfere with that of the EPILAB CCT
6. Patients on antiplatelet or anticoagulant drugs in whom infiltration would be contraindicated.
7. Patients with clinical history of:
a. BHV (AgHbs)
b. VHC (viral load)
c. HIV-I/II
d. HTLV I/II
8. Temporarily patients bacterial infection
9. Women of childbearing age, who do not take non-hormonal contraceptive measures.

1. Pacientes con diabetes o alergias medicamentosas a los tratamientos del estudio.
2. Pacientes con patología epicondilítica recidivante.
3. Pacientes con patología epicondilítica crónica de más de 30 días de evolución.
4. Pacientes con enfermedades importantes de base con esperanza de vida inferior a 1 año o el
tratamiento de las cuales interfiera con los tratamientos del estudio.
5. Enfermedades graves que amenacen la vida en menos de un año o cuyo tratamiento pueda
interferir con los tratamientos del estudio EPILAB.
6. Pacientes que tomen antiagregantes o anticoagulantes ya que contraindica el uso de infiltraciones
7. Personas con antecedentes de:
a. Hepatitis B que son portadores de AgHbs
b. Marcadores positivos del VHC (carga viral)
c. Marcadores positivos para el HIV-I/II
d. Marcadores positivos para HTLV I/II
8. Temporalmente, los pacientes portadores de una infección bacteriana aguda
9. Mujeres en edad fértil que no tomen medidas anticonceptivas (excluidas las hormonales).

E.5 End points

E.5.1

Primary end point(s)

Changes from baseline in:

1) Visual Analog Scale of pain to examination procedures (treatment is considered successful when all scores are <2)
+
2) DASH (Disabilities of the Arm, Shoulder and Hand) activities inventory score (treatment is considered successful when score < 50 points)
+
3) Relapse over one-year (treatment is considered successful when no relapse occurs at 12 months after symptom- onset)

Cambios respecto a la puntuación basal en:

1) Escala Analógica Visual de dolor durante las maniobres de la exploración física (el tratamiento se considera exitoso cuando todas las puntuaciones son < 2 puntos)
+
2) Puntuación del inventario de actividades DASH (Disabilities of the Arm, Shoulder and Hand) (el tratamiento se considera exitoso cuando la puntuación es < 50 puntos)
+
3) Recidiva dentro de los 12 meses desde el inicio de los síntomas (el tratamiento se considera exitoso cuando no hay recidiva a 12 meses desde el inicio de los síntomas)

E.5.1.1

Timepoint(s) of evaluation of this end point

• Baseline on day 1, 7 and 28 after screening
• Reexamination on day 38 days after screening
• Reexamination on day 48 days after screening
• Reexamination on day 58 days after screening
• Reexamination on day 88 days after screening
• Reexamination on day 118 days after screening
• Contact at12 months after screening to ascertain possible relapse

• Basal en el día 1, y a los 7 y 28 días tras la primera visita
• Exploración en el día 38 tras la primera visita
• Exploración en el día 48 tras la primera visita
• Exploración en el día 58 tras la primera visita
• Exploración en el día 88 tras la primera visita
• Exploración en el día 118 tras la primera visita
• Contacto a los 12 meses tras la primera visita para determinar posibles recurrencias

E.5.2

Secondary end point(s)

None

Ninguno

E.5.2.1

Timepoint(s) of evaluation of this end point

Does not apply

No aplica

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

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

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

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:

456

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

456

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)

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

2019-05-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-05-08

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

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