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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2018-001305-82
    Sponsor's Protocol Code Number:IC3627/18
    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:2019-01-22
    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 number2018-001305-82
    A.3Full title of the trial
    Study on the advantages of local post-operative infiltration in forefoot surgery.
    Estudio sobre las ventajas de la infiltración local postoperatoria en la cirugía de antepié
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pain management after bunion surgery
    Manejo del dolor tra la cirugía de juanetes
    A.3.2Name or abbreviated title of the trial where available
    Pain management in forefoot surgery
    Manejo del dolor en cirugía de antepié
    A.4.1Sponsor's protocol code numberIC3627/18
    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 SponsorLaura Perelló Moreno
    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 supportHospital Son Llàtzer
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportClínica Rotger
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Son Llàtzer
    B.5.2Functional name of contact pointTraumatología
    B.5.3 Address:
    B.5.3.1Street Addresscarretera de Manacor s/n
    B.5.3.2Town/ cityPalma de Mallorca
    B.5.3.3Post code07198
    B.5.3.4CountrySpain
    B.5.4Telephone numberEspañ8712020002129
    B.5.6E-maillperell1@hsll.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 levobupivacaine
    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 namelevobupivacaine
    D.3.2Product code 63.171
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Epidural use
    Intramuscular use
    Infiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlevobupivacaina
    D.3.9.1CAS number 27262-48-2
    D.3.9.3Other descriptive nameLEVOBUPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02904MIG
    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 RoleComparator
    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 betametasone
    D.2.1.1.2Name of the Marketing Authorisation holderCelestone
    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 nameceleste
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Dental use
    Infiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbetamethasone
    D.3.9.3Other descriptive nameBETAMETHASONE SODIUM PHOSPHATE
    D.3.9.4EV Substance CodeSUB00784MIG
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    management of postoperative pain in ambulatory foot surgery
    that allows the realization of immediate rehabilitation and better functional results and personal satisfaction
    Manejo del dolor postoperatorio en cirugía ambulatoria de antepie
    que permita la realización de la rehabilitación inmediata y mejores resultados funcionales y de satisfacción personal
    E.1.1.1Medical condition in easily understood language
    Pain management after outpatient foot surgery
    Control del dolor en la cirugía ambulatoria de pie
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To control pain after outpatient forefoot surgery
    controlar de forma eficaz el dolor postoperatorio tras la cirugía ambulatoria de antepié
    E.2.2Secondary objectives of the trial
    To improve the performance of immediate self-rehabilitation
    decrease the need to take rescue analgesia
    improve the degree of personal satisfaction and the final functional result of the patient
    demonstrate that there is no greater risk of complications compared to conventional oral analgesia
    mejorar la realización de la auto-rehabilitación inmediata
    disminuir la necesidad de tomar analgesia de rescate
    mejorar el grado de satisfacción personal y el resultado funcional final del paciente
    demostrar que no existe mayor riesgo de complicaciones respecto a al analgesia oral convencional
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Older than 18 years-old.
    Both genders.
    Types of surgery: Forefoot surgery that includes at least the performance of metatarsal or phalangeal osteotomies and capsular, tendinous or ligamentous soft tissue techniques.
    Surgeries performed under the Major Ambulatory Surgery regimen that meet the pain monitoring and monitoring criteria described.
    Patients who are operated by any of the 3 members of the foot and ankle unit in the two centers Hospital Son Llàtzer and Clinica Rotger.
    Mayor de 18 años.
    Ambos sexos.
    Tipos de cirugía: cirugía de antepié que incluya como mínimo la realización de osteotomía de metatarsianos o falanges y técnicas de partes blandas capsulares, tendinosas o ligamentosas.
    Cirugías realizadas en régimen de Cirugía Mayor Ambulatoria y que cumplan los criterios de seguimiento y monitorización del dolor descritos.
    Pacientes que sean intervenidos por alguno de los 3 miembros de la unidad de pie y tobillo en los dos centros Hospital Son Llàtzer y Clínica Rotger.
    E.4Principal exclusion criteria
    Allergies or intolerances to the medication that is used habitually, making it impossible to administer it.
    History of alcoholism or drug abuse that may influence the effect of the analgesia used.
    History of known psychiatric diseases that may alter the correct collaboration and monitoring by the patient.
    Surgeries that require hospital admission.
    Obesity with Body Mass Index (BMI) greater than 35.
    Appearance of intraoperative or postoperative complications.
    Antecedents of diseases that occur with a decrease in pain threshold, hyperalgesia syndromes or regional anesthesia such as fibromyalgia, neurological or metabolic alterations of sensitivity ...
    Patients undergoing percutaneous forefoot surgery, where osteotomies are performed without the use of osteosynthesis material.
    Alergias o intolerancias a la medicación que se utiliza de forma habitual, haciendo imposible la administración de ésta.
    Antecedentes de alcoholismo o abuso de drogas que pueda influir en el efecto de la analgesia utilizada.
    Antecedentes de enfermedades psiquiátricas conocidas que puedan alterar la correcta colaboración y seguimiento por parte del paciente.
    Cirugías que requieran ingreso hospitalario.
    Obesidad con Índice de Masa Corporal (IMC) mayor a 35.
    Aparición de complicaciones intraoperatorias o postoperatorias.
    Antecedentes de enfermedades que cursen con disminución del umbral del dolor, síndromes de hiperalgesia o anestesia regional tales como fibromialgia, alteraciones neurológicas o metabólicas de la sensibilidad…
    Pacientes sometidos a cirugía percutánea de antepié, donde se realicen osteotomías sin uso de material de osteosíntesis.
    E.5 End points
    E.5.1Primary end point(s)
    Being a prospective study, the study will last the time necessary to recruit the required number of individuals. Subsequently these will be followed for a period of 3 months. Additionally, the analysis and the writing of the results will be carried out to write the article.
    It is expected to last approximately two years.
    Al tratarse de un estudio prospectivo, el estudio durará el tiempo necesario para reclutar el número requerido de individuos. Posteriormente éstos se seguirán durante un período de 3 meses.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Additionally, after the recruitment, the analysis and the writing of the results will be carried out to write the article.
    It is expected to last approximately two years.
    Adicionalmente, tras el reclutamiento, se procederá al análisis y a la redacción de los resultados para redactar el artículo.
    Se prevé una duración aproximada de unos dos años.
    E.5.2Secondary end point(s)
    Subsequently, the analysis of the results will be carried out by a statistical expert and finally, the results will be drafted for presentation at national and / or international congresses and their possible publication in scientific journals.
    Posteriormente, se realizará el análisis de los resultados por un experto estadístico y finalmente, se procederá a la redacción de los resultados para su presentación en congresos de ámbito nacional y/o internacional y su posible publicación en revistas científicas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    This will take between 6 months and a year approximately.
    Esto llevará entre 6 meses y un año aproximadamente.
    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 No
    E.6.5Efficacy No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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
    The last visit of the patient that will be included in the trial is that of the control at three months, later, whether the patient is discharged or requires more clinical control in outpatient clinics, these data will not be taken into account in the results. of the study. Since the medium-term follow-up in our study is considered sufficient.
    La última visita del paciente que se incluirá en el ensayo es la del control a los tres meses, posteriormente, tanto si el paciente es dado de alta como si precisa más control clínico en consultas externas, estos datos no se tendrán en cuenta en los resultados del estudio. Ya que se considera suficiente el seguimiento a medio plazo en nuestro estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 120
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    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 state120
    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
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-14
    P. End of Trial
    P.End of Trial StatusOngoing
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