Clinical Trials Register

Summary
EudraCT Number:	2017-002352-91
Sponsor's Protocol Code Number:	LIDO2017
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:	2018-02-08
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

2017-002352-91

A.3

Full title of the trial

Randomised, Double-blind Clinical Trial to Evaluate the Reduction of Pain in the Wounds Treatment Previously Applying Lidocaine Topical Solution vs Placebo in an outpatient.

Ensayo clínico randomizado doble ciego para evaluar la disminución del dolor en las curas de heridas al aplicar previamente fomentos de lidocaína vs placebo, en paciente ambulatorio

A.3.1

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

Assesing topical analgesia during painful cures.

Evaluación de la analgesia tópica en las curas dolorosas

A.4.1

Sponsor's protocol code number

LIDO2017

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	Dra Antònia Dalmau i LLitjós del Servicio de Anestesia, Reanimación y Terapéutica del dolor del HUB -Idibell
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 universitari de Bellvitge -Idibell
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	Dra Antònia Dalmau i Llitjós. Servicio de Anestesia,Reanimación y Terapéutica del Dolor HUB- Idibell
B.5.2	Functional name of contact point	Servicio de Anestesia,Reanimación y
B.5.3	Address:
B.5.3.1	Street Address	C/Feixa Llarga s/n
B.5.3.2	Town/ city	Hospitalet de Llobregat
B.5.3.3	Post code	08907
B.5.3.4	Country	Spain
B.5.4	Telephone number	34932607323
B.5.5	Fax number	34932607884
B.5.6	E-mail	mdalmau@bellvitgehospital.cat

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	Lidocaina B.Braun 5% solución inyectable
D.2.1.1.2	Name of the Marketing Authorisation holder	B.BRAUN
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	Lidocaína B. Braun 50 mg/ml solución inyectable
D.3.4	Pharmaceutical form	Cutaneous solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	lidocaina
D.3.9.1	CAS number	137-58-6
D.3.9.2	Current sponsor code	LIDO-0,5
D.3.9.3	Other descriptive name	LIDOCAINE HYDROCHLORIDE SOLUTION 0.5%
D.3.9.4	EV Substance Code	SUB96101
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
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	Cutaneous liquid
D.8.4	Route of administration of the placebo	Topical use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Evaluate pain reduction during wound cleaning after previous application of topic solution of lidocaine vs. placebo

Evaluar la reducción del dolor durante la cura de las heridas previa aplicación de fomentos de lidocaina vs Placebo.

E.1.1.1

Medical condition in easily understood language

Evaluate pain reduction during wound cleaning after previous application of a drug on the skin

Evaluar la reduccion del dolor durante la cura de las heridas dolorosas

E.1.1.2

Therapeutic area

Not possible to specify

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

Demonstrate that the application of lidocaine foams prior to wound cleaning, reduces pain of the procedure, compared to the cleaning done after application of saline; with quantified by the reduced value as Verbal Numerical Scale (EVN) with a range of 0 to 10.

Demostrar que la aplicación de los fomentos de lidocaína, previa a la cura de heridas, reduce el dolor del procedimiento, frente a la cura realizada tras la aplicación de suero fisiológico; cuantificándolo por la reducción del valor según la Escala Verbal Numérica (EVN) con un rango de 0 a 10

E.2.2

Secondary objectives of the trial

- To assess the safety of treatment with lidocaine vs. placebo: adverse effects.
- Evaluate if there are differences in the pain score between 5 minutes after the end of the cure, between the cure performed without foments vs the cure performed after applying the study solution foments (Lidocaine or Placebo, as appropriate by randomization)
- Approximate if the time of application, respecting an interval between 7 and 15 minutes, influences the decrease of pain.
- Evaluate if the use of foams during the cure, reduces the pain to the 24 hours following the cure

- Evaluar la seguridad del tratamiento con lidocaína y con placebo: efectos adversos.
- Valorar si a los 5 minutos de haber finalizado la cura, hay diferencias en la puntuación del dolor, entre la cura realizada sin fomentos vs la cura realizada tras aplicar los fomentos de solución de estudio (Lidocaina o Placebo, según corresponda por aleatorización)
- Aproximar si el tiempo de aplicación, respetando un intervalo entre 7 y 15 minutos, influye en el descenso del dolor.
- Evaluar si el uso de fomentos durante la cura, reduce el dolor a las 24 horas siguientes a la cura

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

a) signed and dated informed consent before randomization process
b) male or female
c) older or equal to 18 years
d) Patients with painful wound care
e) Wounds or ulcers of any origin (vascular deficit, diabetic, traumatic, postsurgical ...) with skin damaged
f) Women with a negative result on a pregnancy test.
g) Men and women of childbearing potential must agree to use effective contraception throughout treatment

a) Consentimiento informado firmado y fechado antes del proceso de aleatorización
b) Sexo masculino o femenino
c) Ser mayor o igual a 18 años
d) Pacientes con cura dolorosa de heridas ( EVN ≥ 5) que acudan a consultas externas
e) Heridas o úlceras de cualquier origen con solución de continuidad de la piel de grado II a IV. Salvo ulceras por déficit arterial
f) Mujeres en edad fértil con resultado negativo en test de embarazo.
g) Hombres y mujeres con potencial fértil deben acceder a utilizar un método anticonceptivo eficaz durante todo el tratamiento

E.4

Principal exclusion criteria

a) history of allergic reaction to local anesthetics of the amide type.
b) Wounds or ulcers of grade I (injury seamless skin)
c) very large wounds (requiring more than 20 ml of solution)
d) periocular Wounds
e) Patients with impaired cardiac conduction atrioventricular block of 2nd or 3rd degree heart block or bifascicular
f) Patients with altered level of consciousness
g) Patients on hemodialysis, peritoneal dialysis or continuous hemofiltration
h) Patients with moderate or severe hepatic impairment
i) Pregnant or breast-feeding.
j) Patients who refuse to participate

a) Antecedentes de reacción alérgica a anestésicos locales de tipo amida.
b) Heridas o úlceras de grado I (lesiones sin solución de continuidad de la piel)
c) Heridas muy extensas (que precisen más de 20 ml de la solución)
d) Heridas perioculares
e) Pacientes con alteraciones de la conducción cardíaca: bloqueo auriculoventricular de 2º o 3º grado o bloqueo cardiaco bifascicular
f) Pacientes con nivel de consciencia alterado
g) Pacientes en hemodiálisis, diálisis peritoneal o hemofiltración continua
h) Pacientes con insuficiencia hepática moderada o severa
i)Embarazadas o en periodo de lactancia.
j) Pacientes que rechacen participar

E.5 End points

E.5.1

Primary end point(s)

Differential to score in the EVN (0-10), between the first cure performed without foams vs the cure performed after applying the study solution fomentations (lidocaine or placebo, as appropriate by randomization).

Diferencial de puntuación en la EVN (0-10), entre la cura realizada sin fomentos vs la cura realizada tras aplicar los fomentos de solución de estudio (lidocaína o placebo, según corresponda por aleatorización).

E.5.1.1

Timepoint(s) of evaluation of this end point

The value of the EVN scale after each cure will be obtained.

Se obtendra el valor de la escala EVN durante la cura.

E.5.2

Secondary end point(s)

1. Differential score in the EVN (0-10) at 15 minutes after the end of the cure, between the cure performed without foments vs the cure performed after applying the study solution foments (lidocaine or placebo, as applicable by randomization ).
2. Approximate if the time of application, respecting an interval of between 7 and 15 minutes, influences the decrease of pain.
3.Differential score 24 hours after the cure, between the two cures (no foments vs foments)
4. Clinical monitoring of the occurrence of adverse effects:
4.1. Local complications secondary to the application of lidocaine or placebo
4.2. Systemic complications secondary to absorption of local anesthetic (neurological, cardiovascular, respiratory or other abnormalities) If any symptoms of systemic alteration appear, we would perform an ECG and, if necessary, determine methemoglobinemia. In case of any systemic adverse effects, the anesthesic medical doctor would accompany the patient to the emergency room.

1. Diferencial de puntuación en la EVN (0-10) a los 15 minutos de haber finalizado la cura, entre la cura realizada sin fomentos vs la cura realizada tras aplicar los fomentos de solución de estudio (lidocaína o placebo, según corresponda por aleatorización).
2. Aproximar si el tiempo de aplicación, respetando un intervalo de entre 7 y 15 minutos, influye en el descenso del dolor.
3.Diferencial de puntuación a las 24 horas de haber realizado la cura, entre las dos curas (sin fomentos vs con fomentos)
4. Vigilancia clínica de la aparición de efectos adversos:
4.1. Complicaciones locales secundarias a la aplicación de lidocaína o placebo
4.2. Complicaciones sistémicas secundarias a la absorción de anestésico local (alteraciones neurológicas, cardiovasculares, respiratorias o de cualquier otra índole) Si apareciera cualquier síntoma de alteración sistémica, realizaríamos un ECG y, si precisa, determinación de metahemoglobinemia. En el caso de aparecer cualquier efecto adverso sistémico, el médico de la UDA acompañaría al paciente a urgencias.

E.5.2.1

Timepoint(s) of evaluation of this end point

The secondary end points will be evaluated after each cure and after 24 hours the investigator team will do a follow telephone call visit

las variables secundarias se evaluaran después de cada cura y tras 24 horas el equipo investigador hará una visita de seguimiento telefónica

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

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

Suero fisológico 0,9%

Saline serum 0.9 %

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 study will end when the security call of the last recruited patient is made. LVLS

El estudio finalizará cuando se realice la llamada de seguridad del último paciente reclutado.

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

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)

There won't be plans for treatment or care after the subject has ended the participation in the trial, because the treatment consists in an unique cure

No habrá planes para el tratamiento o cura del sujeto después de finalizar su participación en el ensayo, ya que el tratamiento consiste en una única cura

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-07-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-03-15

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

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IMP with orphan designation in the indication
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