Clinical Trials Register

Summary
EudraCT Number:	2013-000478-32
Sponsor's Protocol Code Number:	B?PRPtendon2013
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:	2013-04-09
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

2013-000478-32

A.3

Full title of the trial

Pilot randomised trial to assess the safety and potential efficacy of platelet rich plasma tenotomy for the treatment of chronic epicondylitis

Estudio clínico piloto aleatorizado para valorar la seguridad y eficacia potencial de la tenotomía con plasma rico en plaquetas (PRP) en la epicondilitis crónica

A.3.1

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

Study to prove the safety and efficacy of platelet rich plasma tenotomy for the treatment of chronic epicondylitis

Estudio para conocer seguridad y eficacia de la tenotomía con plasma rico en plaquetas (PRP) en la epicondilitis crónica

A.3.2

Name or abbreviated title of the trial where available

PRP in tenotomy

PRP en tenopatia

A.4.1

Sponsor's protocol code number

B?PRPtendon2013

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	Jose Ignacio Martin Gomez
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	Basque Goberment
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	Basque Health Service
B.5.2	Functional name of contact point	Isabel Andi Ortiz
B.5.3	Address:
B.5.3.1	Street Address	Plaza de Cruces
B.5.3.2	Town/ city	Barakaldo
B.5.3.3	Post code	48003
B.5.3.4	Country	Spain
B.5.4	Telephone number	00349460060007005
B.5.6	E-mail	isabel.andiaortiz@osakidetza.net

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	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	liquid PRP
D.3.2	Product code	PRPtendon
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use Infiltration
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PRP autologo
D.3.9.1	CAS number	No aplica
D.3.9.2	Current sponsor code	B-PRPtendon
D.3.9.3	Other descriptive name	HUMAN PLASMA PROTEIN
D.3.9.4	EV Substance Code	SUB51727
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	5
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

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

pain in the outer face of the elbow

dolor en la cara externa del codo

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10024032
E.1.2	Term	Lateral epicondylitis
E.1.2	System Organ Class	100000004863

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Assess whether the treatement with PRP improves chronic epicondylitis recalcitrant against lidocaine wet tenotomy, meassured by DASH scale and decreasing pain.

Valorar si la tenotomía con PRP mejora el efecto terapéutico frente a la tenotomía húmeda con lidocaína, en los pacientes
con epicondilitis crónica recalcitrante,
mediante la escala DASH y disminucion del dolor.

E.2.2

Secondary objectives of the trial

To evaluate the clinical efficacy and safety of PRP in chronic epicondylitis
2. Assess structural changes (by ultrasound) in the tendon secondary to treatment with PRP
3. Assess whether the application of this technology is feasible
4. Assess the feasibility of the protocol

Valorar la eficacia clínica y la seguridad del PRP en la epicondilitis crónica
2. Valorar cambios estructurales (mediante ecografía) en el tendón secundarios al tratamiento con
PRP
3. Valorar si la aplicación de esta tecnología es factible a efectos organizativos
4. Valorar la factibilidad del protocolo

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients of both sexes aged 35 to 75 years.
Pain in the arm 3 or more points in VAS.
Values ??of BMI between 20 and 35.
Possibility for observation during the follow up period.
Epicondylitis diagnosed

Pacientes de ambos sexos con edades comprendidas entre los 35 y los 75 años.
Dolor en el brazo igual o superior a 3 puntos en EVA.
Valores de Índice de Masa Corporal entre 20 y 35.
Posibilidad para observación durante el periodo de seguimiento.
Diagnosticados de epicondilitis según los criterios diagnósticos

E.4

Principal exclusion criteria

Body Mass Index> 35
? systemic autoimmune rheumatic disease (connective tissue diseases and vasculitis systemic necrotizing).
? Poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%)
? Blood disorders (thrombopathy, thrombocytopenia, anemia with Hb <9).
? Be undergoing with immunosuppressive therapy and / or warfarin. treatment by
corticosteroids during the 3 months prior to inclusion in the study.
? Treatment with NSAIDs, oral corticosteroids within 15 days
prior to inclusion in the study
? Severe heart disease

Índice de masa corporal>35
? Enfermedad reumática autoinmune sistémica (enfermedades del tejido conectivo y vasculitis
necrotizantes sistémicas).
? Diabetes Mellitus mal controlada (hemoglobina glicosilada superior al 9%)
? Alteraciones hematológicas (trombopatía, trombopenia, anemias con Hb<9).
? Estar siendo sometido a tratamientos inmunosupresores y/o dicumarínicos. Tratamiento mediante
corticoides durante los 3 meses anteriores a su inclusión en el estudio.
? Tratamiento mediante antiinflamatorios no esteroideos, corticoides orales durante los 15 días
previos a su inclusión en el estudio
? Cardiopatía severa

E.5 End points

E.5.1

Primary end point(s)

The percenteage of patients that improve de scale "Form Disabilities of the Arm Shoulder and Harm", (DASH).

Porcentaje de pacientes que mejoran su escala DASH

E.5.1.1

Timepoint(s) of evaluation of this end point

Basal, 6th week, 3,6 and 12 months

Basal, 6ª semana, 3, 6 y 12 mes.

E.5.2

Secondary end point(s)

Variables evolution
On the first visit they passed the visual analogue scale (VAS) to assess pain: You are asked by the
maximum pain caused by epicondylitis and punctuate it on the scale.
VERY IMPORTANT: The patient is 48 hours without taking any pain medication before
EVA complete scales and initial DASH.
Variables relating to the application of treatment
Time of blood collection
Treatment given (A or B)
Intervention location
Duration of intervention (start and end)
Optional charge
Adverse events related to the arm

Variables de evolución
En la primera visita se les pasa la escala analógica visual, (EVA), para valorar dolor: se le preguntará por el
máximo dolor ocasionado por la epicondilitis y que lo puntúe en la escala.
MUY IMPORTANTE: El paciente estará 48 horas sin tomar ningún tipo de medicación analgésica antes de
cumplimentar las escalas EVA y DASH iniciales.
Variables relativas a la aplicación del tratamiento
Hora de extracción sanguínea
Tratamiento administrado (A o B)
Localización de la intervención
Duración de la intervención (hora de inicio y fin)
Facultativo encargado
Acontecimientos adversos relacionados con el brazo

E.5.2.1

Timepoint(s) of evaluation of this end point

Basal, 6th week, 3,6 and 12 months

Basal, 6ª semana, 3, 6 y 12 mes.

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

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

Yes

E.8.2.3.1

Comparator description

lidocaina

lidocaine

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

30 days after the last measseure of the last patient.

30 dias tras la finalizacion de la ultima prueba del último paciente incluido en el estudio

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

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

2013-07-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-05-28

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

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