Clinical Trials Register

Summary
EudraCT Number:	2013-000873-56
Sponsor's Protocol Code Number:	CARPA2013
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:	2013-05-20
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

2013-000873-56

A.3

Full title of the trial

Randomized, two paralel groups, open clinical trial stratified by severity to stimate the cost-effectivity of surgical vs corticosteroid injection treatment on carpal tunnel syndrome

Ensayo clínico randomizado abierto, de dos grupos paralelos, estratificado por severidad para estimar el coste-efectividad de la descompresión quirúrgica vs a la infiltración local con corticoides en el Síndrome de Túnel Carpiano (STC)

A.3.1

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

Randomized, two paralel groups, open clinical trial stratified by severity to stimate the cost-effectivity of surgical vs corticosteroid injection treatment on carpal tunnel syndrome

A.4.1

Sponsor's protocol code number

CARPA2013

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	Federico Diaz González
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 Universitario de Canarias
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	Federico Diaz González
B.5.2	Functional name of contact point	Federico Diaz González
B.5.3	Address:
B.5.3.1	Street Address	Ofra s/n. La Cuesta
B.5.3.2	Town/ city	La Laguna
B.5.3.3	Post code	38320
B.5.3.4	Country	Spain
B.5.4	Telephone number	034922646792
B.5.5	Fax number	034922647112
B.5.6	E-mail	federico.diaz.gonzalez@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	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	Betametasona Acetato, Betametasona Fosfato Sodio
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	Betamethasone Acetate
D.3.9.1	CAS number	987-24-6
D.3.9.3	Other descriptive name	BETAMETHASONE ACETATE
D.3.9.4	EV Substance Code	SUB00780MIG
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	3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Betamethasone Sodium Phosphate
D.3.9.1	CAS number	151-73-5
D.3.9.3	Other descriptive name	BETAMETHASONE DISODIUM PHOSPHATE
D.3.9.4	EV Substance Code	SUB00784MIG
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	3
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

Carpal tunnel syndrome

Síndrome del tunel carpiano

E.1.1.1

Medical condition in easily understood language

Carpal tunnel syndrome

Síndrome del tunel carpiano

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10007697
E.1.2	Term	Carpal tunnel syndrome
E.1.2	System Organ Class	10029205 - Nervous system disorders

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 Know what treatment surgical or local steroid injection is more cost effective accordingly to the severity of carpal tunnel syndrome (mild, moderate, severe)

Conocer qué tratamiento; el médico o el quirúrgico, es más coste- efectivo según la severidad del síndrome del tunel carpiano (leve, moderado, severo) evaluado por clínica y electromiografía al inicio.

E.2.2

Secondary objectives of the trial

1) To describe and analyze the costs of treating patients with STC in this study.
2) To study the complications of both treatments and try to establish causality in order to avoid complications in the future.
3) To assess the specificity and sensitivity of screening and diagnostic tests of CTS.

1) Describir y analizar los Costes derivados del tratamiento de los pacientes con STC en este estudio.
2) Estudiar las complicaciones derivadas de ambos tratamientos e intentar establecer causalidades para evitar que se produzcan en otras ocasiones.
3) Analizar la especificidad y sensibilidad de las pruebas exploratorias y diagnósticas del STC.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Informed consent
2. Patients between 18 and 65 able to answer written questionnaires

3. To satisfy one or more of the following symptoms: pain, paresthesias and / or hypoesthesia in the territory of the median nerve in hands

4. Nerve conduction delay in the electromyogram (EMG)

5. If the patient has bilateral clinically confirmed by EMG, the hand included will be choose by the patient

1. Consentimiento informado firmado.
2. Pacientes entre 18 y 65 años capaces de responder a cuestionarios escritos
3. Que cumpla uno o más de los síntomas siguientes: Dolor, parestesias y/o hipoestesia, en el territorio de inervación del nervio mediano en la mano.
4. Confirmación electrofisiológica de retardo de conducción nerviosa para el nervio mediano.
5. Si el paciente presenta clínica bilateral confirmada por EMG, se incluirá en el ensayo con una de las dos manos según preferencia del paciente.

E.4

Principal exclusion criteria

1. Patients with Known thyroid disease, rheumatic diseases, diabetes, polyneuropathy, renal chronic failure or alcoholism.

2. Patients who where treated previously with corticoid injection in the affected hand.
3. Patients with any pathology in the affected limb of carpal tunnel syndrome (CTS)
4. Patients with suggestive clinical cervicobraquialgias or nerve compression at any other levels.

5. Presence of thenar atrophy or irreversible injury on the median nerve(nerve conduction absence measured by EMG)

6. Contraindication to treatment with corticosteroids (Systemic fungal infection or hypersensitivity to corticosteroids or other components of the injection)

7. Patients with any contraindication to surgery.

8. Serious psychiatric condition.

9. Evidence of uncontrolled concomitant serious illness.

10. Pregnancy

1. Pacientes diagnosticados o en estudio por posible patología tiroidea, enfermedades reumáticas, diabetes, polineuropatía, insuficiencia renal crónica, leucemia, alcoholismo.
2. Pacientes tratados previamente mediante infiltraciones y cirugías en la mano afecta.
3. Pacientes con cualquier patología en el miembro afecto de STC.
4. Pacientes con cervicobraquialgias o clínica sugestiva de compresión nerviosa a otros niveles.
5. Presencia de atrofia tenar o lesión irreversible del nervio Mediano (ausencia de conducción nerviosa medido con EMG)
6. Contraindicación para el tratamiento con corticoides (infección micótica sistémicas o hipersensibilidad a corticoides u otros componentes del fármaco)
7. Pacientes con cualquier contraindicación para la cirugía.
8. Patología psiquiátrica grave.
9. Evidencia de enfermedad grave concomitante no controlada.
10. Embarazo o posibilidad de estarlo.

E.5 End points

E.5.1

Primary end point(s)

Effectiveness (quality of life: test DASH)
Direct costs

Efectividad: medida mediante Calidad de vida (Test DASH)
Coste

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months

12 meses

E.5.2

Secondary end point(s)

Effectiveness: quality of life by Boston test.
Physical examination: Dermal sensitivity (Weber test), trigger tests, hand force, wrist mobility, complications , time to return to daily activity, adverse events,

- Test Boston: calidad de vida
- Sensibilidad cutánea: test de Weber
- Tests de provocación
- Fuerza motriz
- Movilidad medida mediante goniómetro
- Complicaciones (cicatriz, nerviosa, rigidez, atrofia, otras)
- Tiempo de baja
- Tiempo hasta la vuelta a la actividad diaria.

E.5.2.1

Timepoint(s) of evaluation of this end point

12 months

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

Yes

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

Yes

E.8.1.3

Single blind

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

Cirugía

Surgery

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

Last visit of the last subject undergoing the trial

Última visita del último sujeto del ensayo

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

E.8.9.2

In all countries concerned by the trial years

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.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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

Ninguno

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

2013-07-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-04-25

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

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