Clinical Trials Register

Summary
EudraCT Number:	2018-000269-36
Sponsor's Protocol Code Number:	HIPAIN
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:	2018-04-09
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2018-000269-36

A.3

Full title of the trial

Randomized clinical trial to evaluate the efficacy of two techniques against chronic hip pain: cooled radiofrequency over sensitive nerves of the hip, compared to intraarticular injection of steroids and local anestethic under fluoroscopic guidance on the hip.

Estudio piloto, prospectivo, aleatorizado para comparar la eficacia de dos técnicas contra el dolor crónico de cadera: radiofrecuencia cooled sobre la inervación sensitiva de la cadera y la infiltración intra-articular de anestésico local y corticoide.

A.3.1

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

Randomized study to evaluate the efficacy of two techniques against chronic hip pain: radiofrequency over sensitive nerves of the hip, compared injection of steroids and local anestethic into the hip.

Estudio para comparar la eficacia de dos técnicas contra el dolor crónico de cadera: radiofrecuencia cooled sobre la inervación sensitiva de la cadera y infiltración en la cadera de anestésico local y corticoide.

A.3.2

Name or abbreviated title of the trial where available

Randomized trial: radiofrequency versus intraarticular local anesthestic and steroids.

Estudio piloto, prospectivo, aleatorizado para comparar la eficacia de dos técnicas contra el dolor

A.4.1

Sponsor's protocol code number

HIPAIN

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	JORGE ORDUÑA VALLS
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	Hospital Clinico Universitario
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	INCLIVA
B.5.2	Functional name of contact point	JORGE ORDUNA
B.5.3	Address:
B.5.3.1	Street Address	MENENDEZ Y PELAYO 4
B.5.3.2	Town/ city	VALENCIA
B.5.3.3	Post code	46010
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034961973514
B.5.6	E-mail	dr.orduna.dolor@gmail.com

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	TRIGON DEPOT
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb, 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	triamcinolone acetonide
D.3.4	Pharmaceutical form	Solution for injection/infusion
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	TRIAMCINOLONE ACETONIDE
D.3.9.1	CAS number	76-25-5
D.3.9.4	EV Substance Code	SUB04936MIG
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	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.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

Chronic Hip Pain by Osteoarthrosis

Dolor crónico de cadera por Artrosis

E.1.1.1

Medical condition in easily understood language

Chronic hip pain secondary a arthoris

Dolor de cadera por artrosis

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

To evaluate the efficacy of two techniques against chronic hip pain: cooled radiofrequency over sensitive nerves of the hip, compared to intraarticular injection of steroids and local anestethic under fluoroscopic guidance on the hip.

Comparar la eficacia de dos técnicas contra el dolor crónico de cadera: radiofrecuencia cooled sobre la inervación sensitiva de la cadera y la infiltración intra-articular de anestésico local y corticoide.

E.2.2

Secondary objectives of the trial

638/5000
- To compare the improvement of the functional capacity of patients subjected to radiofrequency cooled compared to those treated by intra-articular injection of local anesthetic and corticosteroid measured by the WOMAC and Oxford Hip score scales.
-Compare the duration of the clinical improvement in terms of pain reduction quantified by the VAS scale (visual analog scale) a year after the application of both techniques.
- To compare the improvement of the quality of life of patients subjected to cooled radiofrequency compared to those treated by intra-articular injection of local anesthetic and corticosteroid as measured by the SF 36 scale.

-Comparar la mejoría de la capacidad funcional de los pacientes sometidos a radiofrecuencia cooled respecto a los tratados mediante inyección intra articular de anestésico local y corticoide medida por las escalas WOMAC y Oxford Hip score.
-Comparar la duración de la mejoría clínica en términos de reducción de dolor cuantificada por la escala VAS (escala visual analógica) al año tras la aplicación de ambas técnicas.
- Comparar la mejoría de la calidad de vida de los pacientes sometidos a radiofrecuencia cooled respecto a los tratados mediante inyección intra articular de anestésico local y corticoide medida por la escala SF 36.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1- Patient over 18 years old.
2- Chronic hip pain (more than 3 months) that has not responded to conservative treatment, pharmacological therapy, physiotherapy or TENS).
3- Mechanical pain in the affected limb with a VAS of at least 50 mm during ambulation.
4- Patients for whom it is possible to carry out all the scheduled visits of the study, with the capacity to attend within the established deadlines for the control visits.
5- Greater than 50% improvement in the VAS scale after the two anesthetic blocks performed with local anesthetics of different duration (levobupivacaine 0.25% and mepivacaine 2%)
6- Moderate to severe osteoarthrosis determined with degrees Kellgren-Lawrence II, III, IV.
7- Stable doses of analgesics at least 30 days before starting the study.
8- Patients who have performed the Oxford Hip Score and WOMAC test 3 months or less before the study.
9- Absence of allergy or adverse events known to any of the medications administered: local anesthetics of amide group and iodinated contrasts.
10-Negative pregnancy test (women of childbearing age) and commitment to guarantee contraception during the study

1- Paciente mayor a 18 años.
2- Dolor de cadera crónico (más de 3 meses) que no ha respondido a tratamiento conservador, terapia farmacológica, fisioterapia o TENS).
3- Dolor de tipo mecánico en el miembro afectado con un VAS de al menos 50 mm durante la deambulación.
4- Pacientes para los que es posible realizar todas las visitas programadas del estudio, con capacidad para acudir en los plazos establecidos a las visitas de control.
5- Mejoría mayor al 50% en la escala VAS tras los dos bloqueos anestésicos realizados con anestésicos locales de diferente duración (levobupivacaina 0,25% y mepivacaina 2%)
6- Osteoartrosis moderada a severa determinada con grados Kellgren-Lawrence II, III, IV.
7- Dosis estables de analgésicos al menos durante 30 días antes de iniciar el estudio.
8- Pacientes que han realizado el test Oxford Hip Score y WOMAC 3 meses o menos antes del estudio.
9- Ausencia de alergia o eventos adversos conocidos a alguno de los medicamentos administrados: anestésicos locales de grupo amida y contrastes iodados.
10-Test de embarazo negativo (mujeres en edad fértil) y compromiso de garantizar la anticoncepción durante el estudio

E.4

Principal exclusion criteria

1- Signs of alarm or infection in the joint affects.
2- Signs of active infection, immunosuppression or active HIV.
3- Severe psychiatric illnesses.
4-Patient carrier of hip prosthesis.
5- Pain added to an unexplained weight loss of more than 5% 90 days or less before the start of the study.
6- Pain of root origin established in the affected limb, or neurodegenerative diseases of the peripheral nervous system.
7- Patients with basic tumor pathology or who have had cancer in the five years prior to inclusion.
8- Alterations of the coagulation or taking of anticoagulants / antiaggregants (except aspirin 150 or 300 mg / day) at the beginning of the study, which can not be suspended for basic pathology during a prudent interval for the realization of the technique.
9- Patient who has participated in a clinical study for the previous 30 days in which interventions are performed that may affect the results of the study.
10- Patient with a diagnosis of disorder due to substance abuse or alcoholism.
11- Patient who is in process for the award of a disability or degree of disability.
12- Pregnant or lactating patient.
13- Patient under treatment with opioids with doses greater than the equivalent to 90 milligrams of oral morphine / day.

1- Signos de alarma o infección en la articulación afecta.
2- Signos de infección activa, inmunosupresión o VIH activo.
3- Enfermedades psiquiátricas severas.
4-Paciente portador de prótesis de cadera.
5- Dolor sumado a una pérdida no explicada de peso de más del 5% 90 días o menos antes del inicio del estudio.
6- Dolor de origen radicular establecido en la extremidad afectada, o enfermedades neurodegenerativas del Sistema nervioso periférico.
7- Pacientes con patología tumoral de base o que hayan tenido cáncer en los cinco años previos a la inclusión.
8- Alteraciones de la coagulación o toma de anticoagulantes/antiagregantes (salvo aspirina 150 o 300 mg/día) al inicio del estudio, que no puedan ser suspendidos por patología de base durante un intervalo prudente para la realización de la técnica.
9- Paciente que haya participado en un estudio clínico los 30 días previos en los que se realizan intervenciones que pueden afectar a los resultados del estudio.
10- Paciente con diagnóstico de trastorno por abuso de sustancias o alcoholismo.
11- Paciente que se encuentre en trámites para la adjudicación de una baja o grado de incapacidad.
12- Paciente embarazada o en periodo de lactancia.
13- Paciente bajo tratamiento con opioides con dosis mayores que la equivalente a 90 miligramos de morfina oral/día.

E.5 End points

E.5.1

Primary end point(s)

a)-Improvement more than 50% in VAS score in patients under treatment with Intraarticular injection or cooled radiofrequency
b)-Duration of the clinical effect in terms of pain reduction (quantified by a 50% reduction in the VAS scale with respect to the baseline level)

- Porcentaje de sujetos con mejoría en los dos grupos definido como reducción del VAS mayor al 50 % respecto al basal a los tres meses desde la aplicación de la técnica.
-Comparar la persistencia del efecto clínico en términos de reducción de dolor (cuantificada por una reducción del 50% en la escala VAS respecto al nivel basal) a los seis meses tras la aplicación de la radiofrecuencia cooled sobre ramas nerviosas sensitivas de la cadera respecto a la inyección intra articular
de anestésico local y corticoide.

E.5.1.1

Timepoint(s) of evaluation of this end point

a)-3 months
b)-6 months

a)3 meses
b) 6 meses

E.5.2

Secondary end point(s)

- Compare the improvement of the functional capacity of patients subjected to radiofrequency cooled compared to those treated by intra-articular injection of local anesthetic and corticosteroid measured by the WOMAC and Oxford Hip score scales.
-Compare the duration of the clinical improvement in terms of pain reduction quantified by the VAS scale (visual analog scale) a year after the application of both techniques.
- To compare the improvement of the quality of life of patients subjected to cooled radiofrequency compared to those treated by intra-articular injection of local anesthetic and corticosteroid as measured by the SF 36 scale.

E.5.2.1

Timepoint(s) of evaluation of this end point

-One month from treatments day.
-Thee months from treatments day.
-Six Months from treatments day.
-12 Months from treatments day.
-24 Months from treatments day.

- Un mes tras el tratamiento
- Tres meses tras el tratamiento
- Seis meses tras el tratamiento
- 12 meses tras el tratamiento
- 24 meses tras el 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

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

cooled radiofrequency

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

Yes

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:

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)

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

2018-05-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-04-26

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials