Clinical Trials Register

Summary
EudraCT Number:	2014-003969-24
Sponsor's Protocol Code Number:	EstudioDOLBEN
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-12-10
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

2014-003969-24

A.3

Full title of the trial

Randomized clinical trial to analysis of pain after administration intramuscular benzathine penicillin needle gauge and length greater local anesthetic or not, in the administration with a traditional intramuscular needle with or without local anesthetic in patients with syphilis. Dolben Study .

Ensayo Clínico aleatorizado para el análisis del dolor tras administración intramuscular de penicilina-benzatina con agujas de mayor calibre y longitud con anestésico local o no, frente a la administración con una aguja intramuscular tradicional con o sin anestésico local, en pacientes con sífilis. Estudio DOLBEN.

A.3.1

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

Analysis of pain after intramuscular injection of penicillin with larger gauge needles and local anesthetic versus traditional needle without anesthetic in patients with syphilis.

Análisis del dolor tras inyección intramuscular de penicilina con agujas de mayor calibre y anestésico local, frente a aguja tradicional sin anestésico en pacientes con sífilis.

A.3.2

Name or abbreviated title of the trial where available

Dolben Study

Estudio Dolben.

A.4.1

Sponsor's protocol code number

EstudioDOLBEN

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	Vicente Estrada Pérez
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	FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA HOSPITAL CLÍNICO SAN CARLOS
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	VICENTE ESTRADA PÉREZ
B.5.2	Functional name of contact point	UNIDAD DE ENFERMEDADES INFECCIOSAS
B.5.3	Address:
B.5.3.1	Street Address	C/PROFESOR MARTIN LAGOS SN
B.5.3.2	Town/ city	MADRID
B.5.3.3	Post code	28040
B.5.3.4	Country	Spain
B.5.4	Telephone number	349133030002774
B.5.5	Fax number	349133035153515
B.5.6	E-mail	vicente.estrada@salud.madrid.org

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.2.1.2	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	BENZYLPENICILLIN SODIUM
D.3.2	Product code	SUB13038MIG
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	BENZYLPENICILLIN SODIUM
D.3.9.1	CAS number	69-57-8
D.3.9.2	Current sponsor code	PENICILINA
D.3.9.4	EV Substance Code	SUB13038MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U unit(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	600000 to 2400000
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: 2
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	LIDOCAINE
D.2.1.1.2	Name of the Marketing Authorisation holder	BRAUN MEDICAL
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	SUB12644MIG
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	LIDOCAINE
D.3.9.2	Current sponsor code	LIDOCAINE
D.3.9.3	Other descriptive name	LIDOCAINE 1%
D.3.9.4	EV Substance Code	SUB12644MIG
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Pain due to intramuscular injection in syphilis.

Dolor secundario a inyección intramuscular en sífilis.

E.1.1.1

Medical condition in easily understood language

Pain

Dolor

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.1
E.1.2	Level	PT
E.1.2	Classification code	10062120
E.1.2	Term	Syphilis
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Analyze if administration of penicillin in patients with syphilis with 19G needle, with or without lidocaine is associated with a reduction in pain compared to intramuscular administration with a 21G needle with or without lidocaine in the intramuscular injection.

Analizar si la administración de Penicilina en pacientes con sífilis mediante aguja 19G, asociado o no a lidocaína se relaciona con una reducción del dolor en la inyección intramuscular comparado con la administración con una aguja de 21G con o sin Lidocaína en la inyección intramuscular.

E.2.2

Secondary objectives of the trial

To analyze the evolution of pain after administration of intramuscular penicillin in patients with syphilis at 6 and 24 h after injection with a 19 G needle with or without lidocaine versus injection administered with a 21 G needle with or without lidocaine.

Analizar la evolución del dolor tras la administración de Penicilina intramuscular en pacientes con sífilis a las 6h y 24 h posteriores a la inyección con una aguja 19 G con o sin lidocaína frente a la inyección administrada con una aguja 21 G con o sin Lidocaína.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Support diagnosis of syphilis by serology (syphilis IgG + / + VDRL / TPHA + RPR + with) in the presence or absence of symptoms or clinical signs.
Need for treatment with intramuscular penicillin 2400000 U.
Acceptance to participate in the study after signing the informed consent.

Diagnóstico de sífilis mediante serología compatible (Sífilis IgG+/VDRL+/TPHA+ junto con RPR+), en presencia o no de síntomas o signos clínicos compatibles.
Necesidad de tratamiento con Penicilina intramuscular 2400000 U.
Aceptación a participar en el estudio tras la firma del consentimiento informado.

E.4

Principal exclusion criteria

Diagnosis of neurosyphilis associated with possible impairment of sensory perception of pain after administration of the drug.
Cognitive impairment who are unable or have difficulty understanding and evaluating the degree of pain on the visual analogue scale (VAS).
Background hipersensibililidad to beta-lactams.
Known hypersensitivity to lidocaine.
Confinement in prison.

Diagnóstico de neurosífilis relacionado con posible alteración de la percepción sensorial del dolor tras la administración del fármaco.
Deterioro cognitivo que sean incapaces o tengan dificultades para comprender y evaluar el grado del dolor en la escala analógica visual (EVA).
Antecedentes de hipersensibililidad a betalactámicos.
Antecedentes de hipersensibilidad a Lidocaína.
Reclusión en centros penitenciarios.

E.5 End points

E.5.1

Primary end point(s)

Pain evolution after administration of intramuscular penicillin.

Evolución del dolor tras la administración de Penicilina intramuscular.

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline, 6 and 24 hours post-injection.

Basal, 6 y 24 horas post-inyeción.

E.5.2

Secondary end point(s)

Demographic: Age, sex, etnic orign.
Anthropometric: Weight, height, BMI, circumference arm and thigh.
Pathological: HIV Infection; RPR value at the time of the inclusion in the study and 6 months later; clinical stage of syphilis (primary, secondary, latent).
Ischemic lesions, neurological deficits due to ischemic compromise of the sciatic nerve; paresis and paralysis corresponding to the injection member.
Discoloration and loss of function of the member to administration area.
Local irritant reaction.

Demográficas: Edad, sexo, raza.
Antropométricas: Peso, talla, índice de masa corporal, circunferencia del brazo y del muslo.
Patológicas: Infección VIH; Valor del RPR en el momento de la inclusión en el estudio y 6 meses después; estadio clínico de la sífilis (primaria, secundaria, latente).
Lesiones isquémicas, déficits neurológicos por compromiso isquémico del nervio ciático; paresias y parálisis del miembro correspondiente a la zona de inyección.
Cambio de coloración e impotencia funcional del leg correspondiente a la
zona de administración.
Reacción irritativa local.

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline, 6 and 24 hours post-injection.

Basal, 6 y 24 horas post-inyeción.

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

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)

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.

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

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-12-10.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

Yes

F.3.3.4

Nursing women

Yes

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

104

F.4.2

For a multinational trial

F.4.2.1

In the EEA

104

F.4.2.2

In the whole clinical trial

104

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

2014-02-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-09-18

P. End of Trial
P.	End of Trial Status	Completed

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