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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-003969-24
    A.3Full 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.3.1Title 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.3.2Name or abbreviated title of the trial where available
    Dolben Study
    Estudio Dolben.
    A.4.1Sponsor's protocol code numberEstudioDOLBEN
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVicente Estrada Pérez
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA HOSPITAL CLÍNICO SAN CARLOS
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVICENTE ESTRADA PÉREZ
    B.5.2Functional name of contact pointUNIDAD DE ENFERMEDADES INFECCIOSAS
    B.5.3 Address:
    B.5.3.1Street AddressC/PROFESOR MARTIN LAGOS SN
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number349133030002774
    B.5.5Fax number349133035153515
    B.5.6E-mailvicente.estrada@salud.madrid.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBENZYLPENICILLIN SODIUM
    D.3.2Product code SUB13038MIG
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBENZYLPENICILLIN SODIUM
    D.3.9.1CAS number 69-57-8
    D.3.9.2Current sponsor codePENICILINA
    D.3.9.4EV Substance CodeSUB13038MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number600000 to 2400000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name LIDOCAINE
    D.2.1.1.2Name of the Marketing Authorisation holderBRAUN MEDICAL
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLIDOCAINE
    D.3.2Product code SUB12644MIG
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIDOCAINE
    D.3.9.2Current sponsor codeLIDOCAINE
    D.3.9.3Other descriptive nameLIDOCAINE 1%
    D.3.9.4EV Substance CodeSUB12644MIG
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    Pain due to intramuscular injection in syphilis.
    Dolor secundario a inyección intramuscular en sífilis.
    E.1.1.1Medical condition in easily understood language
    Pain
    Dolor
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10062120
    E.1.2Term Syphilis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.2.2Secondary 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.2.3Trial contains a sub-study No
    E.3Principal 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.4Principal 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.5.1Primary end point(s)
    Pain evolution after administration of intramuscular penicillin.
    Evolución del dolor tras la administración de Penicilina intramuscular.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 6 and 24 hours post-injection.
    Basal, 6 y 24 horas post-inyeción.
    E.5.2Secondary 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.5.2.1Timepoint(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.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women 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.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state104
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In 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
    No
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-18
    P. End of Trial
    P.End of Trial StatusCompleted
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