Clinical Trials Register

Summary
EudraCT Number:	2012-001056-19
Sponsor's Protocol Code Number:	HUPA-EC-02-2012
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-08-14
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

2012-001056-19

A.3

Full title of the trial

ROLE OF BIOLOGICAL THERAPY IN ROTATOR CUFF TENDINOPATHY. EFFECTIVENESS OF PLASMA RICH IN GROWTH FACTOR (PRGF-ENDORET)REGARDING TO FUNCTIONAL CAPACITY AND PAIN COMPARED WITH THE CONVENTIONAL TREATMENT USING STEROIDS

PAPEL DE LA TERAPIA BIOLOGICA EN LA TENDINOPATIA DEL MANGUITO DE LOS ROTADORES. EECTIVIDAD DEL PLASMA RICO EN FACTORES DE CRECIMIENTO (PRGF-ENDORET) RESPECTO A LA CAPACIDAD FUNCIONAL Y EL DOLOR EN COMPARACIÓN CON EL TRATAMIENTO CONVENCIONAL MEDIANTE CORTICOIDES.

A.3.1

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

EFFECT OF PLASMA RICH IN GROWTH FACTORS IN ROTATOR CUFF TENDINOPATHY

EFECTO DEL PLASMA RICO EN FACTORES DE CRECIMIENTO EN LAS LESIONES DEL MAGUITO DE LOS ROTADORES.

A.4.1

Sponsor's protocol code number

HUPA-EC-02-2012

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	FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA DEL HOSPITAL UNIVERSITARIO PRÍNCIPE DE ASTURIAS
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	fundacion para la investigacion biomedica del hospital universitario principe de asturias
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	FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA DEL HOSPITAL UNIVERSITARIO PRÍNCIPE DE ASTURIAS
B.5.2	Functional name of contact point	Clinical Trials Information
B.5.3	Address:
B.5.3.1	Street Address	Ctra. Alcalá ? Meco s/n
B.5.3.2	Town/ city	Alcalá de Henares
B.5.3.3	Post code	28805
B.5.3.4	Country	Spain
B.5.4	Telephone number	+3491887 81 002605
B.5.5	Fax number	+3491882 26 74
B.5.6	E-mail	fundacion.hupa@gmail.com

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	plasma rich in growth factors
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraarticular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	plasma rich in growth factors
D.3.9.3	Other descriptive name	HUMAN PLASMA FOR FRACTIONATION
D.3.9.4	EV Substance Code	SUB12043MIG
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	6 to 8
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	Yes
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.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	Celestone cronodose
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp and Dohme de España, S.A.
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.3.1	Product name	celestone cronodose
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraarticular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BETAMETHASONE ACETATE
D.3.9.1	CAS number	987-24-6
D.3.9.4	EV Substance Code	SUB00780MIG
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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

ROTATOR CUFF TENDINOPATHY

LESION DEL MAGUITO DE LOS ROTADORES

E.1.1.1

Medical condition in easily understood language

ROTATOR CUFF TENDINOPATHY

LESION DEL MAGUITO DE LOS ROTADORES

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10039226
E.1.2	Term	Rotator cuff injury
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Show more effectiveness after 6 months of treatment with PRGF-Endoret, with an improvement in the reference tests (UCLA and QuickDash) of more than 15% compared to the treatment with corticosteroids

Mostrar la mayor efectividad a los 6 meses del tratamiento con PRGF, con una mejoría en los test de referencia (UCLA y QuickDash) superior al 15% en comparación con tratamiento con corticoides.

E.2.2

Secondary objectives of the trial

To valorate effectiveness after 12 months of treatment with PRGF-Endoret
Quantification of platelet derived growth factor levels in patients treated with PRGF-Endoret and its correlation with the clinical effect

Valorar la efectividad a los 12 meses del tratamiento con PRGF-Endoret.
Cuantificación de la concentración del factor de crecimiento derivado de plaquetas en los pacientes tratados con PRGF-Endoret y su correlación con el efecto clínico.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients between 40 and 70 years old
Male and female
Mild to severe symptoms according to the QuickDASH scale over 3 months of evolution.
Patients with tendinitis, inflammatory or calcium, tendinosis or partial tears of the rotator cuff, diagnosed by ultrasound, evaluated by an expert radiologist independent of the research team.
Patients refractory to the conservative treatment.

Pacientes con edades comprendidas entre 40 y 70 años
Ambos sexos.
Sintomatología moderada a severa según la escala QuickDASH de más de 3 meses de evolución.
Paciente con diagnóstico ecográfico de tendinitis, inflamatoria o cálcica, tendinosis o roturas parciales del manguito de los rotadores. Valorado por un radiólogo experto independiente del equipo investigador.
Pacientes refractarios al tratamiento conservador.

E.4

Principal exclusion criteria

Patients with complete tear of the rotator cuff diagnosed by ultrasound or MRI.
Patients who have previously received treatment with corticoids infiltrations in the last 6 months.
Patients with arterial hypertension or diabetes mellitus poorly controlled.
Patients allergic to some of the medicines in the study or some of their excipients.
Patients treated with anticoagulants or antiplatelet that could not be stopped temporarily for the study.
Inability to understand health questionnaires and / or complete them properly.
Patients uncapable to give informed consent.
Fertile women that do not have a negative pregnancy test before being included in the study.
Breastfeeding women.

Pacientes con diagnóstico de rotura completa del manguito de los rotadores ya sea ecográficamente como por resonancia magnética.
Pacientes que hayan recibido previamente tratamiento mediante infiltraciones con cortocoides en los últimos 6 meses.
Pacientes con HTA o DM mal controlados.
Pacientes que presenten alergias a algunos de los medicamentos del estudio o a algunos de sus excipientes.
Pacientes en tratamiento con anticoagulantes o antiagregantes que no puedan revertirse temporalmente para las infiltraciones.
Incapacidad para entender los cuestionarios de salud y/o completarlos adecuadamente.
Pacientes sin capacidad de otorgar el consentimiento informado.
Mujeres que podrán estar embarazadas y que no tienen un test de embarazo negativo en el momento de iniciar el estudio.
Mujeres en periodo de lactancia

E.5 End points

E.5.1

Primary end point(s)

Improvement of more than 15% in the reference tests UCLA and QuickDash after 6 months of treatment with PRGF-Endoret compared to treatment with corticoids.

Mejoría de más de un 15% en los tests de referencia UCLA y QuickDash después de 6 meses con tratamiento de PRGF-Endoret comparado con el tratamiento con corticoides.

E.5.1.1

Timepoint(s) of evaluation of this end point

6 months

6 meses

E.5.2

Secondary end point(s)

Effectiveness of PRGF-Endoret treatment after 12 months.
sex
age
Degrees of cuff injury measured by ultrasounds,
laterality
Employment status at present (Working, unemployed or retired),
Complications
Quantification of platelet derived growth factor (PDGF) concentration in all patients in the study group if posible.

Efectividad a los 12 meses del tratamiento con PRGF-Endoret
Sexo
Edad,
Grados de lesión del manguito por ecografía
Lateralidad,
Situación laboral en la actualidad (Activos, parados o pensionistas),
Presencia de complicaciones acontecidas
Cuantificación de la concentración del factor de crecimeinto derivado de plaquetas (PDGF) en todos los pacientes del grupo de estudio si fuera posible.

E.5.2.1

Timepoint(s) of evaluation of this end point

3,6 and 12 months

3,6 y 12 meses

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

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)

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

Yes

E.8.1.7.1

Other trial design description

Evaluación ciega por terceros

With blind assessment by third parties

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

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

The trial will be also finished when:
There is a significative increase of adverse events that could put the objective, effectiveness and security of the trial at risk.
Significative inferior results in the experimental arm at the intermediate analysis.

El ensayo finalizará también en los siguientes casos:
Aumento significativo de reacciones adversas que pongan en duda la eficacia y la seguridad del producto en investigación.
Resultados significativamente inferiores del grupo de estudio en los análisis provisionales intermedios.

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)

Yes

F.1.3.1

Number of subjects for this age range:

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

Yes

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)

The expected normal treatment for that condition

Tratamiento habitual normal

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

2013-12-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-06-24

P. End of Trial
P.	End of Trial Status	Completed

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