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    Summary
    EudraCT Number:2015-004482-88
    Sponsor's Protocol Code Number:FAR-DOL-2015
    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:2016-03-18
    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 number2015-004482-88
    A.3Full title of the trial
    Randomized clinical trial to compare the safety and effectiveness of metamizol, ibuprofen and tramadol added to a fixed dose of paracetamol in the treatment of post- surgical pain in patients ? 80 year after an intervention to repare a fracture of the proximal third of the femur, admitted to a convalescence unit
    Ensayo clínico aleatorizado para comparar la seguridad y efectividad de metamizol, ibuprofeno y tramadol añadidos a una pauta fija de paracetamol, en el tratamiento de dolor post-quirúrgico después de una intervención por fractura del tercio proximal de fémur en pacientes de ? 80 años ingresados en la Unidad de Convalecencia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized clinical trial to compare the safety and effectiveness of metamizol, ibuprofen and tramadol combined with paracetamol in the treatment of pain after a surgical intervention to repair a femur fracture in patients >= 80 years admitted Convalescence Unit
    Ensayo clínico aleatorizado para comparar la seguridad y efectividad de metamizol, ibuprofeno y tramadol combinados con paracetamol, en el tratamiento de dolor después de una intervención quirúrgica por fractura del fémur en pacientes de >= 80 años ingresados en la Unidad de Convalecencia
    A.4.1Sponsor's protocol code numberFAR-DOL-2015
    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 SponsorFundació Parc Taulí
    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 supportFundació Parc Taulí
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitari Parc Taulí
    B.5.2Functional name of contact pointOficina de Recerca
    B.5.3 Address:
    B.5.3.1Street AddressParc Taulí, 1
    B.5.3.2Town/ citysabadell
    B.5.3.3Post code08208
    B.5.3.4CountrySpain
    B.5.4Telephone number34937458451
    B.5.5Fax number34937175067
    B.5.6E-mailafarre@tauli.cat
    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.2.1.2Country 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 nameIbuprofeno
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIBUPROFEN
    D.3.9.3Other descriptive nameIBUPROFEN
    D.3.9.4EV Substance CodeSUB08098MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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.2.1.2Country 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 namemetamizol
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETAMIZOLE
    D.3.9.1CAS number 50567-35-6
    D.3.9.3Other descriptive namemetamizole
    D.3.9.4EV Substance CodeSUB03187MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number575
    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: 3
    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.2.1.2Country 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 nameTramadol
    D.3.4Pharmaceutical form Oral drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRAMADOL
    D.3.9.3Other descriptive nameTRAMADOL
    D.3.9.4EV Substance CodeSUB11210MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    The medical condition being studied is post surgical pain following surgery for femur fracture in patients ? 80 years old
    La condición médica estudiada es el dolor postquirúrgico después de cirugía por fractura de fémur en pacientes ? 80 años.
    E.1.1.1Medical condition in easily understood language
    Pain after surgery for femur fracture in patients ? 80 years old
    Dolor después de la cirugía por fractura de fémur en pacientes ? 80 años.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10054711
    E.1.2Term Postoperative pain
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the safety of three analgesic regimens for the treatment of pain in patients ? 80 years after femur fracture surgery.
    Comparar la seguridad de tres regímenes analgésicos para el tratameinto del dolor en pacientes ? 80 años sometidos a cirugía por fractura de fémur.
    E.2.2Secondary objectives of the trial
    To compare, in qualitative terms, the safety of analgesic treatment between metamizol, ibuprofen and tramadol in elderly patients with fracture of the proximal femur during the first week and at weeks 2, 3 and 4 after surgery.
    -To compare, in quantitative terms, the safety of analgesic treatment between metamizol, ibuprofen and tramadol in elderly patients with fracture of the proximal femur at weeks 2, 3 and 4 postsurgery.
    -To compare the analgesic effectiveness of the three treatments up to week 4 postsurgery.
    -Comparar, en términos cualitativos, la seguridad del tratamiento analgésico entre metamizol, ibuprofeno y tramadol en pacientes ancianos post-operados por fractura del tercio proximal del fémur durante la primera semana y en las semanas 2, 3 y 4 del postoperatorio.
    -Comparar, en términos cuantitativos, la seguridad del tratamiento analgésico entre metamizol, ibuprofeno y tramadol en pacientes ancianos post-operados por fractura del tercio proximal del fémur en las semanas 2, 3 y 4 del postoperatorio.
    -Comparar la efectividad de las tres pautas analgésicas hasta la semana cuatro post intervención
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients ? 80 years
    -Patients undergoing surgery for fracture of the proximal femur
    -Patients candidates for oral treatment with any of the study drugs
    -Patients who give their informed consent to participate in the study
    -Pacientes ? 80 años
    -Pacientes intervenidos por fractura del tercio proximal del fémur
    -Pacientes candidatos a recibir tratamiento oral con cualquiera de los fármacos del estudio
    -Pacientes que otorguen su consentimiento informado a participar en el estudio
    E.4Principal exclusion criteria
    Patients who, at the discretion of the investigator are not able to consent or participate in study assessments (Neurologic impairment such as senile dementia or other that may impair the pain assessment and response to analgesic treatment)
    Patients with contraindications to the drugs studied according to the summary of product characteristics (SPC).
    Patients with creatinine clearance <50 ml / min
    Patients with blood dyscrasias (anemia, thrombocytopenia, agranulocytosis, aplastic anemia)
    Patients with severe hypotension
    Patients with hepatic cirrosis or previous upper gastrointestinal bleeding
    Patients on chronic treatment with drugs that may not be administered together with the study medication according to the SPC
    Patients receiving treatment with NSAIDs, metamizol or opioids in a continuous schedule with good compliance reported within the previous month before inclusion into the study. As needed consumption within the previous month are allowed.
    Patients with chronic pain that could interfere with the study assessments
    The physician responsible for patient's care considers that the participation of the patient in the study could be a prejudice
    Pacientes que, según criterio del investigador no sean capaces de otorgar su consentimiento o de participar en las evaluaciones del estudio (alteraciones neurológicas como demencia senil o otras que puedan dificultar la valoración de la escala del dolor i la respuesta al tratamiento analgésico)
    Pacientes con contraindicaciones a los fármacos estudiados según ficha técnica
    Pacientes con aclaramiento de creatinina <50ml/min
    Pacientes con discrasias hemáticas (anemia, trombopenia, agranulocitosis, aplasia medular)
    Pacientes con hipotensión severa
    Pacientes con cirrosis hepática o antecedentes de hemorragia digestiva alta
    Pacientes en tratamiento crónico con fármacos que su administración concomitante con la medicación en estudio esté contraindicada según ficha técnica
    Pacientes que reciben, como mínimo durante el último mes previo a la inclusión en el estudio, tratamiento con AINEs, metamizol u opioides con una pauta continua y para la que el paciente refiere buen cumplimiento. Las pautas a demanda en el mes previo al estudio estarán permitidas
    Pacientes con dolor crónico que a criterio del investigador pueda interferir en las valoraciones del estudio
    Pacientes en los que se considere que su participación en el estudio puede suponer un perjuicio clínico, en opinión del médico responsable del cuidado del paciente
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of complications related to the study medication during the first week after surgery, assessed as the frequency in each group of, at least, one of the following:
    -Adverse events of moderate intensity in any of the following signs and symptoms: high blood pressure, edema, dyspepsia, nausea, vomiting, bleeding, worsening of respiratory function, confusion, agitation, decreased level of consciousness, or laboratory abnormalities in the blood count or biochemical determinations of liver function, kidney or ions.
    -Serious adverse events of any kind.
    -withdrawal of the study medication due to any reason different from insufficient pain control
    Proporción de complicaciones de la medicación asignada en el estudio durante la primera semana del post-operatorio, evaluada como la frecuencia de aparición en cada grupo de al menos uno de los siguientes:
    -Acontecimientos adversos de intensidad moderada en alguno de los siguientes signos y síntomas: presión arterial, edemas, dispepsia, nauseas, vómitos, sangrados, empeoramiento de la función respiratoria, confusión, agitación, disminución del nivel de consciencia, o alteraciones analíticas en el hemograma o en las determinaciones bioquímicas de función hepática, renal o iones.
    -Acontecimientos adversos graves de cualquier tipo.
    -Retirada de la medicación asignada en el estudio por cualquier causa diferente al mal control del dolor.
    E.5.1.1Timepoint(s) of evaluation of this end point
    One week after surgery.
    una semana después de la cirugía.
    E.5.2Secondary end point(s)
    - Efficacy variables:
    Weekly percentage of pain measures < 3 on a 11 item Verbal Pain Scale (VPS) (0 = no pain to 10 = worst pain imaginable), up to week 4 postsurgery.
    Summary of different parameters derived from the VPS measures.
    Duration of treatment with the assigned study regimen
    Number of doses of painkillers received daily
    Use of rescue medication
    Withdrawal from the study because of insufficient pain control
    Security variables:
    Frequency of appearance in the first 4 weeks:
    Adverse events of mild intensity in any of the following signs and symptoms: blood pressure, edema, dyspepsia, nausea, vomiting, bleeding, worsening of respiratory function, confusion, agitation, decreased level of consciousness or laboratory abnormalities in the blood count or the biochemical determinations of liver function, kidney or ions.
    Adverse events of moderate intensity in any of the following signs and symptoms: high blood pressure, edema, dyspepsia, nausea, vomiting, bleeding, worsening of respiratory function, confusion, agitation, decreased level of consciousness or laboratory abnormalities in the blood count or the biochemical determinations of liver function, kidney or ions .
    Serious adverse events of any kind.
    Stopping the assigned study medication for any reason.
    Withdrawal from the study for any reason other than poor pain control.
    Frequency of complications to the study medication during weeks 2, 3 and 4 after surgery, assessed as the frequency in each group of at least one of the following:
    Adverse events of moderate intensity in any of the following signs and symptoms: high blood pressure, edema, dyspepsia, nausea, vomiting, bleeding, worsening of respiratory function, confusion, agitation, decreased level of consciousness, or laboratory abnormalities in the blood count or in biochemical determinations of liver function, kidney or ions.
    Serious adverse events of any kind
    Stopping the assigned study medication for any reason.
    - Variables de eficacia:
    Porcentaje semanal de medidas con dolor menor a 3 en una Escala Verbal de Dolor (EVD) de 11 ítems (0 = sin dolor a 10= máximo dolor imaginable), hasta la semana 4 post IQ.
    Resumen de los distintos parámetros derivados de los puntajes de dolor en las distintas determinaciones del EVD.
    Duración del tratamiento con la pauta asignada del estudio
    Número de dosis de analgésicos recibidas diariamente
    Utilización de dosis de rescate
    Retirada del estudio por mal control del dolor
    -Variables de Seguridad:
    Frecuencia de aparición en las primeras 4 semanas de:
    Acontecimientos adversos de intensidad leve en alguno de los siguientes signos y síntomas: presión arterial, edemas, dispepsia, nauseas, vómitos, sangrados, empeoramiento de la función respiratoria, confusión, agitación, disminución del nivel de consciencia o alteraciones analíticas en el hemograma o en las determinaciones bioquímicas de función hepática, renal o iones.
    Acontecimientos adversos de intensidad moderada en alguno de los siguientes signos y síntomas: presión arterial, edemas, dispepsia, nauseas, vómitos, sangrados, empeoramiento de la función respiratoria, confusión, agitación, disminución del nivel de consciencia o alteraciones analíticas en el hemograma o en las determinaciones bioquímicas de función hepática, renal o iones..
    Acontecimientos adversos graves de cualquier tipo
    Retirada de la medicación asignada en el estudio por cualquier causa
    Retirada del estudio por cualquier causa distinta del mal control del dolor
    Frecuencia de aparición de complicaciones de la medicación asignada en el estudio durante las semanas 2, 3 y 4 del postoperatorio, evaluada como la frecuencia de aparición en cada grupo de al menos uno de los siguientes:
    Acontecimientos adversos de intensidad moderada en alguno de los siguientes signos y síntomas: presión arterial, edemas, dispepsia, nauseas, vómitos, sangrados, empeoramiento de la función respiratoria, confusión, agitación, disminución del nivel de consciencia, o alteraciones analíticas en el hemograma o en las determinaciones bioquímicas de función hepática, renal o iones.
    Acontecimientos adversos graves de cualquier tipo
    Retirada de la medicación asignada en el estudio por cualquier causa diferente al mal control del dolor.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the first 4 weeks postsurgery.
    Durante las primeras 4 semanas post-operación.
    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 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
    Last patient last visit
    Ultima 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 months5
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state180
    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 Decision2016-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-15
    P. End of Trial
    P.End of Trial StatusOngoing
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