Clinical Trials Register

Summary
EudraCT Number:	2014-004120-21
Sponsor's Protocol Code Number:	COX1985
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:	2015-06-15
Trial results	View 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

2014-004120-21

A.3

Full title of the trial

CLINICAL TRIAL RANDOMIZED, DOUBLE-BLIND CONTROLLED, PHASE III, TO EVALUATE THE USE OF PLATELET RICH PLASMA IN FRONT HYALURONIC ACID IN COXARTHROSIS.

ENSAYO CLÍNICO ALEATORIZADO, DOBLE CIEGO, CONTROLADO, FASE III, PARA EVALUAR EL USO DE PLASMA RICO EN PLAQUETAS FRENTE A ÁCIDO HIALURÓNICO EN COXARTROSIS.

A.3.1

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

CLINICAL TRIAL RANDOMIZED, DOUBLE-BLIND CONTROLLED, PHASE III, TO EVALUATE THE USE OF PLATELET RICH PLASMA IN FRONT HYALURONIC ACID IN COXARTHROSIS.

ENSAYO CLÍNICO ALEATORIZADO, DOBLE CIEGO, CONTROLADO, FASE III, PARA EVALUAR EL USO DE PLASMA RICO EN PLAQUETAS FRENTE A ÁCIDO HIALURÓNICO EN COXARTROSIS.

A.4.1

Sponsor's protocol code number

COX1985

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 PÚBLICA ANDALUZA PROGRESO Y SALUD
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	FUNDACIÓN PÚBLICA ANDALUZA PROGRESO Y SALUD
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 PÚBLICA ANDALUZA PROGRESO Y SALUD
B.5.2	Functional name of contact point	MARTA REBOREDO ARES
B.5.3	Address:
B.5.3.1	Street Address	AVENIDA AMÉRICO VESPUCIO Nº5 BLOQUE 2-2
B.5.3.2	Town/ city	SEVILLA
B.5.3.3	Post code	41092
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034955040450
B.5.5	Fax number	0034955040457
B.5.6	E-mail	gestionensayosclinicos.fps@juntadeandalucia.es

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	platelet rich plasma
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	Platelet rich plasma
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	equal
D.3.10.3	Concentration number	6
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.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	Synvisc - One
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi
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	Synvisc - One
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	HYALURONIC ACID
D.3.9.1	CAS number	9004-61-9
D.3.9.3	Other descriptive name	HYALURONIC ACID
D.3.9.4	EV Substance Code	SUB14126MIG
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	10
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	Yes
D.3.11.13.1	Other medicinal product type	Medical Device

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

coxarthrosis

coxartrosis

E.1.1.1

Medical condition in easily understood language

coxarthrosis

coxartrosis

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	10058417
E.1.2	Term	Hyaluronic acid
E.1.2	System Organ Class	10022891 - Investigations

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 evaluate the efficacy and safety of platelet rich plasma (PRP) in patients with coxarthrosis

Evaluar la eficacia y seguridad del plasma rico en plaquetas (PRP) en los pacientes con coxartrosis.

E.2.2

Secondary objectives of the trial

To evaluate the efficacy and safety of platelet rich plasma (PRP) in patients with coxarthrosis

Evaluar la eficacia y seguridad del plasma rico en plaquetas (PRP) en los pacientes con coxartrosis.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patients> 30 years.
- Patients who voluntarily express their intention to participate by informed consent.
- Diagnosis of coxarthrosis who have failed conservative treatments for 6 months
- Women of childbearing potential must have a negative pregnancy test during screening and must agree to use adequate contraception (or two contraceptive methods, of which one is barrier) while participating in the trial.

- Pacientes > 30 años.
- Pacientes que expresen voluntariamente su intención de participar mediante el consentimiento informado.
- Diagnóstico de coxartrosis que han fallado los tratamientos conservadores durante 6 meses
- Las mujeres en edad fértil deberán de tener una prueba de embarazo negativa durante la selección y deben comprometerse a utilizar un método anticonceptivo apropiado (o dos métodos anticonceptivos, de los cuáles uno sea de barrera) durante su participación en el ensayo.

E.4

Principal exclusion criteria

- Treatment with infiltrations 3 months prior to the study
- Prior treatment with NSAIDs 24h prior to extraction
- Pre-Surgical Treatment of Hip affects
- Diabetics
- Severe liver or kidney disease at the time of extraction
- Thrombocytopenia (<100,000 platelets / ml) at baseline
- Anemia (Hb 9 <mg / dl) at baseline
- Hyaluronic acid Allergy
- History crystal arthropathy, inflammatory arthritis or neuropathic arthropathy.
- Acetabular protrusions
- History of infectious arthritis
- Excessive deformity (acetabular dysplasia, Perthes)

- Tratamiento con infiltraciones los 3 meses anteriores al estudio
- Tratamiento previo con aines 24h previas a la extracción
- Tratamiento quirúrgico previo sobre la cadera afecta
- Diabéticos
- Enfermedad renal o hepática grave, en el momento de la extracción
- Plaquetopenia (<100.000 plaquetas/ml) al inicio del estudio
- Anemia (Hb 9<mg/dl) al inicio del estudio
- Alergia a ácido hialurónico
- Historia de artropatía por cristales, artritis inflamatoria o artropatía neuropática.
- Protusiones acetabulares
- Antecedente de artritis infecciosa
- Deformidad excesiva (displasia acetabular, Perthes)

E.5 End points

E.5.1

Primary end point(s)

An analysis of qualitative endpoint WOMAC (range 0-100) between the two treatment groups at month infiltration is performed. To evaluate the functional differences of both groups the Student t test or nonparametric variant in the case of not meeting the normal distribution is used.

Se realizará un análisis de la variable cualitativa de eficacia WOMAC (rango de 0 a 100) entre los dos grupos de tratamiento al mes de la infiltración. Para evaluar las diferencias funcionales de ambos grupos se utilizará la prueba t de Student o su variante no paramétrica en el caso de no cumplir la distribución normal.

E.5.1.1

Timepoint(s) of evaluation of this end point

E.5.2

Secondary end point(s)

To evaluate the correlation of platelet concentration and the concentration values of different chondrocyte growth factors with clinical response test bivariate Pearson correlation or nonparametric alternative (Spearman's Rho) will be used. This evaluation will be done by measuring the WOMAC scale a week and a month.

To assess the various factors together with clinical response of the patient will be done through a linear regression model. This model also values the baseline characteristics of patients and the severity of coxarthrosis measured by the scale of Tönnis, BMI, seasonality data, disease progression is included.

Para evaluar la correlación de la concentración de plaquetas y los valores de la concentración de los distintos factores de crecimiento del condrocito con la respuesta clínica del paciente se utilizará el test de la correlación bivariada de Pearson o su alternativa no paramétrica (Rho de Spearman). Esta evaluación se hará con la medición de la escala WOMAC a la semana y al mes.

Para valorar los distintos factores juntos con la respuesta clínica del paciente se hará mediante un modelo de regresión lineal. En este modelo se incluirán además valores de las características basales de los pacientes como la gravedad de la coxartrosis medido por la escala de Tönnis, IMC, estacionalidad de los datos, evolución de la enfermedad.

E.5.2.1

Timepoint(s) of evaluation of this end point

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)

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

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

sinvisc

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

usual clinical practice

Práctica clínica habitual

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

F.3.3.2

Women of child-bearing potential using contraception

Yes

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)

usual clinical practice

práctica clínica habitual

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

2016-01-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-10-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-05-24

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