Clinical Trials Register

Summary
EudraCT Number:	2019-000538-21
Sponsor's Protocol Code Number:	PRP-GTPS-2019
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:	2019-04-12
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

2019-000538-21

A.3

Full title of the trial

PAINFUL SYNDROME OF THE MAJOR TROCANTER: Randomized clinical trial with masked evaluation of parallel groups to evaluate the efficacy and safety of the sub-fascial infiltration of PRP compared with wet tenotomy.

SINDROME DOLOROSO DEL TROCANTER MAYOR: Ensayo clínico, aleatorizado, con evaluación enmascarada de grupos paralelos para evaluar la eficacia y seguridad de la Infiltración sub-fascial de PRP en comparación con la tenotomía húmeda.

A.3.1

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

A.4.1

Sponsor's protocol code number

PRP-GTPS-2019

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	ISABEL ANDIA ORTIZ
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	Instituto de Investigación Sanitaria BioCruces Bizkaia
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	LEIRE ATILANO SANTOS
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	C/ Plaza de Cruces nº 12
B.5.3.2	Town/ city	Barakaldo
B.5.3.3	Post code	48903
B.5.3.4	Country	Spain
B.5.6	E-mail	LEIRE.ATILANOSANTOS@osakidetza.eus

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	Platelets Rich Plasma
D.3.2	Product code	PRP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intralesional use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Platelet Rich Plasma
D.3.9.2	Current sponsor code	PRP
D.3.9.3	Other descriptive name	HUMAN PLASMA
D.3.9.4	EV Substance Code	SUB126372
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 7
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	Lidocaine
D.2.1.1.2	Name of the Marketing Authorisation holder	B Braun Medical 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	Lidocaine
D.3.2	Product code	Lidocaine
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intralesional use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LIDOCAINE
D.3.9.2	Current sponsor code	Lidocaine
D.3.9.4	EV Substance Code	SUB08507MIG
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	3 to 5
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	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	Calcium chloride
D.2.1.1.2	Name of the Marketing Authorisation holder	B Braun Medical 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	Calcium chloride
D.3.2	Product code	Calcium chloride
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intralesional use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Calcium Chloride
D.3.9.1	CAS number	10043-52-4
D.3.9.3	Other descriptive name	CALCIUM CHLORIDE ANHYDROUS
D.3.9.4	EV Substance Code	SUB13168MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µl microlitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	350
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

Painful syndrome of the greater trochanter (chronic GTPS)

Síndrome doloroso del trocánter mayor (GTPS crónico)

E.1.1.1

Medical condition in easily understood language

Painful syndrome of the greater trochanter

Síndrome doloroso del trocánter mayor

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

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 the potential efficacy of fenestration with PRS tendon in the symptomatic treatment of chronic GTPS versus wet tenotomy with lidocaine by comparing the success rate at follow-up visit 2 (6 months after treatment), between the groups of fenestration with PRP and wet tenotomy with lidocaine.

Evaluar la eficacia potencial de la fenestración con tendón con PRP en el tratamiento sintomático del GTPS crónico frente a la tenotomía húmeda con lidocaína a través de la comparación de la tasa de éxito en la visita de seguimiento 2 (6 meses desde el tratamiento), entre los grupos de fenestración con PRP y tenotomía húmeda con lidocaína.

E.2.2

Secondary objectives of the trial

Assess the safety of fenestration with PRP in the symptomatic treatment of chronic GTPS versus wet tenotomy with lidocaine through: a) comparing the frequency, intensity and severity of adverse events and adverse reactions in the period between initial visit and three months after the treatment visit (follow-up visit 1) To evaluate the potential efficacy of fenestration with PRP tendon in the symptomatic treatment of chronic GTPS versus wet tenotomy with lidocaine by comparing the rate of success in the follow-up visit 2 (6 months from the treatment), between the groups of fenestration with PRP and wet tenotomy with lidocaine.

Evaluar la seguridad de la fenestración con PRP en el tratamiento sintomático del GTPS crónico frente a la tenotomía húmeda con lidocaína a través de: a) la comparación de la frecuencia, intensidad y severidad de los acontecimientos adversos y reacciones adversas en el período comprendido entre la visita de inicio y tres meses tras la visita de tratamiento (visita de seguimiento 1) Evaluar la eficacia potencial de la fenestración con tendón con PRP en el tratamiento sintomático del GTPS crónico frente a la tenotomía húmeda con lidocaína a través de la comparación de la tasa de éxito en la visita de seguimiento 2 (6 meses desde el tratamiento), entre los grupos de fenestración con PRP y tenotomía húmeda con lidocaína.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

683/5000
- Patients of both sexes aged between 35 and 75 years.
- In the selection visit, they present hip pain at 3 points out of 10 in EVA.
- Body Mass Index values between 20 and 35 (both values included).
- Commitment to comply with all the study procedures.
- Diagnosed chronic GTPS according to the diagnostic criteria that have been previously described.
- The patient must give his informed consent in writing.
- Women of childbearing potential must obtain a negative result in the blood or urine pregnancy test and accept the use of adequate contraceptive methods while remaining in the trial.

- Pacientes de ambos sexos con edades comprendidas entre los 35 y los 75 años.
- En la visita de selección, presentan dolor en cadera a 3 puntos sobre 10 en EVA.
- Valores de Índice de Masa Corporal entre 20 y 35 (ambos valores incluidos).
- Compromiso para cumplir con todos los procedimientos del estudio.
- Diagnosticados de GTPS crónica según los criterios diagnósticos que se han descrito previamente.
- El paciente debe otorgar su consentimiento informado por escrito.
- Las mujeres en edad fértil deberán obtener un resultado negativo en la prueba de embarazo en sangre u orina y aceptar el empleo de métodos anticonceptivos adecuados mientras que se permanezca en el ensayo.

E.4

Principal exclusion criteria

- Body mass index> 35.
- Patients with a diagnosis of complete tendon rupture.
- Systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis).
- Diabetes Mellitus poorly controlled (glycosylated hemoglobin greater than 9%).
- Hematological alterations (thrombopathy, thrombocytopenia, anemia with Hb <9 gr / dl).
- Being subjected to immunosuppressive treatments.
- Treatment by intramuscular corticoid, during the 3 months prior to the first administration of the trial treatment.
- Treatment by non-steroidal anti-inflammatory drugs (more than 10 consecutive days at usual doses), opiates or oral corticosteroids during the 15 days prior to treatment in the study.
- Severe heart disease.
- Patients who can not comply with the scheduled visits.
- Patients with active cancer or with cancer diagnosed in the last 5 years.
- Analytical diagnosis of Hepatitis B, C or HIV infection.
- Women who are pregnant or breast-feeding.
- Patients who are taking a drug in the clinical research phase or have participated in a study in the clinical research phase (with an authorized product or not) within 30 days prior to randomization.
- Any physical, social or psychological problem that, in the opinion of the investigators, may affect the patient's participation in the trial or the validity of the data obtained by participating in it.

- Índice de masa corporal>35.
- Pacientes con diagnóstico de rotura completa de tendón.
- 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 gr/dl).
- Estar siendo sometido a tratamientos inmunosupresores.
- Tratamiento mediante corticoide intramuscular, durante los 3 meses anteriores a la primera administración del tratamiento del ensayo.
- Tratamiento mediante antiinflamatorios no esteroideos (más de 10 días consecutivos a dosis habituales), opiáceos o corticoides orales durante los 15 días previos al tratamiento en el estudio.
- Cardiopatía severa.
- Pacientes que no puedan cumplir con las visitas programadas.
- Pacientes con cáncer activo o con cáncer diagnosticado en los últimos 5 años.
- Diagnóstico analítico de Hepatitis B, C o infección VIH.
- Mujeres embarazadas o en periodo de lactancia.
- Pacientes que estén tomando un fármaco en fase de investigación clínica o hayan participado en algún estudio en fase de investigación clínica (con un producto autorizado o no) en los 30 días previos a su aleatorización.
- Cualquier problema físico, social o psicológico que, en opinión de los investigadores, pueda afectar a la participación del paciente en el ensayo o a la validez de los datos obtenidos por su participación en el mismo.

E.5 End points

E.5.1

Primary end point(s)

The difference in the percentage of therapeutic success obtained in the intervention group (fenestration with PRP) with respect to the group of wet tenotomy with lidocaine.

La diferencia en el porcentaje de éxito terapéutico obtenido en el grupo intervención (fenestración con PRP) con respecto al grupo de tenotomía húmeda con lidocaína.

E.5.1.1

Timepoint(s) of evaluation of this end point

6 months from the end of the treatment.

6 meses desde el final del tratamiento.

E.5.2

Secondary end point(s)

Description of frequency, type, intensity and severity of adverse events and adverse reactions in each treatment group in the period between the initial visit and three months after the treatment visit and comparison between groups.

Descripción de frecuencia, tipo, intensidad y severidad de acontecimientos adversos y reacciones adversas en cada grupo de tratamiento en el período comprendido entre la visita de inicio y tres meses tras la visita de tratamiento y comparación entre grupos.

E.5.2.1

Timepoint(s) of evaluation of this end point

6 months from the end of the treatment.

6 meses desde el final del tratamiento.

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

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)

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 duration of the clinical trial has been established at 12 months for each of the participating patients, with a twelve-month recruitment period to reach the 80 patients needed in the study.

La duración del ensayo clínico se ha establecido en 12 meses para cada uno de los pacientes participantes, con un período de reclutamiento de doce meses de duración para alcanzar los 80 pacientes necesarios 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

2019-09-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-08-09

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

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