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    Summary
    EudraCT Number:2007-003656-11
    Sponsor's Protocol Code Number:A0081171
    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:2007-10-09
    Trial results View 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 number2007-003656-11
    A.3Full title of the trial
    ESTUDIO ALEATORIZADO, DOBLE CIEGO, MULTICÉNTRICO, DE DETERMINACIÓN DE DOSIS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE PREGABALINA EN COMPARACIÓN CON PLACEBO COMO TRATAMIENTO COMPLEMENTARIO DEL DOLOR POSTOPERATORIO TRAS LA REPARACIÓN DE UNA HERNIA INGUINAL PRIMARIA

    A RANDOMIZED, DOUBLE BLIND MULTI CENTER DOSE RANGING STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN COMPARED TO PLACEBO IN THE ADJUNCTIVE TREATMENT OF POST SURGICAL PAIN AFTER PRIMARY INGUINAL HERNIA REPAIR
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberA0081171
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer, S.A
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.2.1.1.1Trade name Lyrica
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNPregabalina
    D.3.9.1CAS number 148-553-50-8
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Lyrica
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNPregabalina
    D.3.9.1CAS number 148-553-50-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 Lyrica
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNPregabalina
    D.3.9.1CAS number 148-553-50-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    DOLOR POSTOPERATORIO

    POST SURGICAL PAIN
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036236
    E.1.2Term Postoperative pain relief
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal de este estudio es valorar la eficacia de la pregabalina en comparación con la del placebo sobre el dolor agudo 24 horas después de una herniorrafia inguinal programada.
    E.2.2Secondary objectives of the trial
    Evaluar el efecto de la pregabalina en el dolor con el movimiento y en reposo después de la intervención.
    Efectos de la pregabalina en la Evaluación global de la medicación del estudio
    Evaluar la seguridad y la tolerabilidad de la pregabalina en el perioperatorio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes varones de 18 a 75 años.
    2. El paciente ha otorgado su consentimiento informado por escrito, que debe obtenerse antes de su admisión en el estudio.
    3. El paciente va a someterse a una herniorrafia inguinal unilateral abierta programada, utilizando una malla Lichtenstein bajo anestesia general; se administrará fentanilo o sufentanilo/propofol como anestesia inicial y sevoflurano o isoflurano como mantenimiento más infiltración de anestésico local, al final de la intervención. La intervención quirúrgica del estudio debe estar programada por la mañana.
    4. Se espera que el paciente pueda usar y tolerar AINE, tramadol, oxicodona y paracetamol para el control del dolor postoperatorio.
    5. El paciente deberá acudir a una visita en las 72 h anteriores al día de la operación si no es ingresado la noche antes para realizar una evaluación basal y recibir la medicación del estudio antes del día previo a la operación.
    6. Se espera que el paciente acceda a permanecer ingresado en el hospital (o en una unidad de cuidados intermedios) durante al menos 3 horas después de la intervención.
    7. La salud preoperatoria del paciente es de grado P1 o P2 ASA (véase el Apéndice A).
    8. La salud del paciente es satisfactoria según determine el investigador a partir de la historia clínica, la exploración física y los resultados de laboratorio.
    9. Prueba de un documento de consentimiento informado, firmado y fechado personalmente, en el que se indique que el paciente (o su representante legal) ha sido informado de todos los aspectos pertinentes del estudio.
    10. Pacientes dispuestos a cumplir las visitas programadas, el plan de tratamiento, los análisis clínicos y otros procedimientos del estudio y capaces de hacerlo.
    E.4Principal exclusion criteria
    1. Pacientes que se sometan a otros procedimientos al mismo tiempo que a la herniorrafia inguinal total
    2. Pacientes sometidos a una intervención no programada o de urgencia o que tengan una hernia incarcerada
    3. La reparación de la hernia no es una reparación primaria
    4. Bloqueo nervioso o anestesia espinal/epidural/paravertebral o cirugia no programadas bajo anestesia general
    5. Pacientes en los que esté contraindicado el uso de los anestésicos indicados en el protocolo y de anestesia general
    6. Pacientes que hayan estado utilizando cualquier opiáceo durante más de 2 semanas para el control del dolor en los tres meses anteriores a la visita de selección
    7. Pacientes con alguna alteración cognitiva que, en opinión del investigador, impida que participen en el estudio o que cumplan los procedimientos exigidos en el protocolo, entre ellos, la cumplimentación minuciosa del diario y el cumplimiento del tratamiento
    8. Pacientes con alguna enfermedad relacionada con la movilidad o el dolor que limite la evaluación de las mediciones realizadas al sentarse y al caminar
    9. Pacientes con antecedentes de abuso del alcohol, de analgésicos o de narcóticos (según los criterios del DSM IV) en los 12 meses previos a la selección
    10. Pacientes con antecedentes de intolerancia o hipersensibilidad clínicamente significativas a la pregabalina, la gabapentina, la oxicodona, los AINE, el tramadol, el paracetamol y/o cualquier analgésico que tenga sensibilidad cruzada con los medicamentos que se utilizan en este estudio
    11. Pacientes que hayan tenido úlcera o hemorragia esofágica, gástrica, pilórica o duodenal, ya sean activas o con sospecha de padecerlas, en los 60 días anteriores a la operación
    12. Uso de los medicamentos prohibidos enumerados en este protocolo en ausencia de la fase de lavado apropiada, o probabilidad de que durante el período de estudio se precise tratamiento con fármacos no permitidos por el protocolo del estudio
    13. Pacientes con antecedentes de úlcera o hemorragia digestivas altas, infarto de miocardio, isquemia miocárdica (angina) inestable, trombosis venosa profunda o embolia pulmonar en los tres meses previos a la intervención
    14. En opinión del investigador, el paciente presenta hipovolemia de importancia clínica
    15. Pacientes con enfermedad intestinal inflamatoria, trastorno renal o hepático agudo o crónico o defecto importante de la coagulación
    16. Paciente con antecedentes o presencia recurrente de asma o broncospasmo que necesita tratamiento con glucocorticoides
    17. Pacientes con antecedentes de enfermedades crónicas no controladas que, en opinión del investigador, contraindicarían su participación en el estudio o confundirían la interpretación de los resultados.
    18. La salud preoperatoria del paciente es de grado P3 ASA o mayor
    19. Pacientes en tratamiento oncológico (es decir, cirugía, quimioterapia, radioterapia, etc.) o en remisión de cualquier tipo de cáncer, aparte del carcinoma basocelular o el carcinoma epidermoide, en los 2 años previos a la selección
    20. Pacientes que recibieron pregabalina en los 30 días anteriores a la visita de selección o que vayan a recibir cualquier fármaco en investigación durante este estudio o en los 30 días siguientes a la selección
    21. Cualquier alteración médica o analítica inestable o clínicamente importante que, a criterio del investigador, pueda poner en peligro la participación en el ensayo
    22. Pacientes que posiblemente vayan a necesitar analgésicos u otros productos no citados en el protocolo entre el final de la intervención y el final del período de tratamiento, que puedan confundir las respuestas a los analgésicos
    23. Se excluyen expresamente los antidepresivos tricíclicos y los ISRN, los antiepilépticos, los neurolépticos, los antieméticos neurolépticos, los inhibidores de la COX, los narcóticos y los corticosteroides. Los pacientes que reciban prevención antitrombótica con ácido acetilsalicílico en dosis ≤325 mg/día podrán continuar con este tratamiento. Podrán participar los pacientes tratados con inhibidores selectivos de la recaptación de serotonina (ISRS) en dosis estables desde 30 días antes de la intervención y mientras dure el estudio que se encuentren estables (sin ideaciones suicidas ni otros síntomas significativos combatidos por los ISRS)
    24. Pacientes que hayan tomado cualquier AINE o analgésico distinto del paracetamol en los 2 días previos a la visita basal y a la intervención o que no estén dispuestos a abstenerse de tomar otros analgésicos durante el estudio (salvo en las excepciones que se especifican en el protocolo)
    25. Cualquier otro trastorno médico o psiquiátrico grave, agudo o crónico, o cualquier anomalía de laboratorio que pueda aumentar el riesgo asociado a la participación en el estudio o a la administración del producto en investigación o interferir en la interpretación de los resultados del estudio y, en opinión del investigador, impedir la participación en este estudio
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal es el peor dolor comunicado por los pacientes (1.ª pregunta de la versión abreviada del Inventario breve del dolor modificado) el primer día (unas 24 horas) después de la intervención.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months6
    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 months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female No
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 400
    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 Decision2007-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-14
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