Clinical Trials Register

Summary
EudraCT Number:	2015-000796-28
Sponsor's Protocol Code Number:	ECO-INTERMIOFASCIAL-4444
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:	2015-06-15
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

2015-000796-28

A.3

Full title of the trial

A pilot, single-blind, placebo-controlled study to assess efficacy and safety of interfascial blockade of the painful trapezius muscle in patients with fribromyalgia

EFICACIA Y SEGURIDAD DEL BLOQUEO INTER-FASCIAL EN EL TRATAMIENTO DEL DOLOR EN EL TRAPECIO DE PACIENTES CON FIBROMIALGIA: ESTUDIO PILOTO, ENMASCARADO A CIEGO SIMPLE Y CONTROLADO CON PLACEBO

A.3.1

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

Study comparing the effect on pain and function of an anaesthetic injection with a placebo (non-active substance) for the treatment of pain at the trapezius muscle.

Estudio que compara el efecto de una inyección anestésica en el dolor del músculo trapecio en pacientes con fibromialgia, comparado con una inyección de placebo (una sustancia sin actividad) sobre el dolor y otros síntomas funcionales

A.4.1

Sponsor's protocol code number

ECO-INTERMIOFASCIAL-4444

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	Fundacio Clinic per a la Recerca Biomèdica
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 Clinic Barcelona
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	Hospital Clinic Barcelona
B.5.2	Functional name of contact point	Unidad de Fibromialgia
B.5.3	Address:
B.5.3.1	Street Address	Villarroel 170
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08036
B.5.3.4	Country	Spain
B.5.4	Telephone number	34932275400

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	Yes
D.2.1.1.1	Trade name	Bupivacaína B. Braun 2,5 mg/ml solución inyectable.
D.2.1.1.2	Name of the Marketing Authorisation holder	B. Braun Medical S.A. Ctra. Terrassa, 121 08191 Rubí (Barcelona)
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.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Bupivacaíne hidrocloruro
D.3.9.3	Other descriptive name	BUPIVACAINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB00902MIG
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	2.5
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.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intramuscular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Trapezius muscle pain in patients with fibromyalgia

Dolor en el músculo trapecio en pacientes con fibromialgia

E.1.1.1

Medical condition in easily understood language

Trapezius muscle pain in patients with fibromyalgia

Dolor en el músculo trapecio en pacientes con fibromialgia

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	10048439
E.1.2	Term	Fibromyalgia
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue 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 compare the degree and duration of pain control in patients with fibromyalgia after a single injection of bupivacaine or placebo between trapezius and supraspinatus muscles

Comparar la eficacia en la mejoría del dolor del trapecio y su duración, en pacientes con fibromialgia sometidos a la administración regional de bupivacaina o placebo, en el espacio interfacial entre los músculos trapecio y supraespinoso.

E.2.2

Secondary objectives of the trial

To compare the degree and duration of pain control in patients with fibromyalgia after a single injection of bupivacaine or placebo between trapezius and supraspinatus muscles

Comparar la mejoría del dolor y duración del efecto, en pacientes con fibromialgia a los que se inyecta un anestésico (bupivacaina) o un placebo, en el espacio entre los músculos del cuello (trapecio y supraespinoso)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age 18 or more
2. Patients diagnosed of Fibromyalgia as primary cause of pain, according ACR 1990 criteria
3. Not treated or on stable treatment for the last 3 months
4. Spontaneous continuous pain at the upper trapezius muscle for more than three months with a VAS intensity above 4,
5. Signed Written informed consent.

1. Mayores de 18 años.
2. - Pacientes que sufren de Fibromialgia como enfermedad principal y causa de su dolor, diagnosticada con criterios de ACR 1990
3. Pacientes que no han iniciado un tratamiento nuevo, o reciben un tratamiento estable en los últimos tres meses.
4. Presencia de dolor espontaneo, continuo, en el trapecio superior derecho y/o izquierdo de más de tres meses de duración, con una escala de intensidad del dolor con esta localización superior a 4, según EVA
5. Firma del consentimiento informado.

E.4

Principal exclusion criteria

1.Any non-controlled condition or disease (cardiovascular, endocrine, etc)
2. Other neuromuscular, infectious, metabolic or inflammatory diseases.
3. Current anticoagulant therapy or coagulation abnormalities
4. Prior surgery at shoulder or spine level
5. Active vertebral disease (cervical or thoracic)
6. Joint or tendon disease affecting shoulder area
7. Intolerance or hypersensitivity to bupivacaine or other local anaesthetic agents
8. Pregnant or nursing women
9. Skin lesions at the injection site
10. Implantable devices for pain neuromodulation
11. Patients undergoing the procedure previously

1. Presencia de otras enfermedades metabólicas, endocrinológicas, cardiovasculares y viscerales no controladas.
2. Presencia de otras enfermedades neuromusculares infecciosas, metabólicas o inflamatorias.
3. Alteración de la coagulación o pacientes en tratamiento con anticoagulantes
4. Antecedentes de Cirugía en columna cervical y/o hombros.
5. Presencia de enfermedad vertebral activa en los segmentos cervical y/o dorsal.
6. Presencia de enfermedad tendinosa o articular activa que afecte a hombros
7. Intolerancia, hipersensibilidad o alergia a la Bupivacaina o a otros anestésicos locales.
8. Pacientes embarazadas o en periodo de lactancia.
9. Presencia de lesiones en la piel, eccemas, infecciones dérmicas en el área de administración del fármaco (trapecios).
10. Dispositivos eléctricos implantados por el tratamiento del dolor (neuromodulación).
11. Pacientes sometidos a este tipo de procedimento con anterioridad

E.5 End points

E.5.1

Primary end point(s)

Regional pain VAS at the trapezius muscle

Escala Analógica Visual (EVA) de dolor regional del trapecio seleccionado para tratamiento,

E.5.1.1

Timepoint(s) of evaluation of this end point

measured at weeks 2, 4 and 12 after treatment

semanas 2, 4 y 12.

E.5.2

Secondary end point(s)

General pain VAS
Sleep quality Pittsburg Index (PSQI)
Functional capacity(FIQ)
QoL (SF-36)
Anxiety / Deppression (HAD)

Escala Analógica Visual (EVA) de dolor general del paciente.
Valoración del sueño: Índice de Pittsburg (PSQI)
Capacidad Funcional (FIQ)
Calidad de Vida (SF-36)
Nivel de ansiedad / Depresión (HAD)

E.5.2.1

Timepoint(s) of evaluation of this end point

measured at weeks 2, 4 and 12 after treatment

semanas 2, 4 y 12.

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)

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

Yes

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

LVLS

última visita del último paciente incluido

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

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

2015-08-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-05-12

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

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