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    Summary
    EudraCT Number:2014-002309-39
    Sponsor's Protocol Code Number:60/2011
    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:2015-06-01
    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 number2014-002309-39
    A.3Full title of the trial
    EFFECTIVENESS OF ROPIVACAINE 0.1% INTRAPERITONEAL IN POSTOPERATIVE PAIN CONTROL IN GYNECOLOGIC LAPAROSCOPIC SURGERY "
    EFICACIA DE LA ROPIVACAINA 0,1% INTRAPERITONEAL EN EL CONTROL DEL DOLOR POSTOPERATORIO EN CIRUGIA GINECOLÓGICA LAPAROSCOPICA"
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness of local anesthetic in controlling abdominal pain in laparoscopic gynecological surgery.
    Eficacia de la anestesia local intraabdominal en el control del dolor abdominal en la cirugia ginecologica laparoscopica.
    A.4.1Sponsor's protocol code number60/2011
    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 SponsorOsakidetza
    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 supportnone
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital de Galdakao
    B.5.2Functional name of contact pointServicio de Anestesia
    B.5.3 Address:
    B.5.3.1Street AddressLabeaga auzoa s/n
    B.5.3.2Town/ cityGaldakao
    B.5.3.3Post code48690
    B.5.3.4CountrySpain
    B.5.4Telephone number34944007030
    B.5.5Fax number34944007076
    B.5.6E-mailunai.ortegamera@osakidetza.net
    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 Naropin
    D.2.1.1.2Name of the Marketing Authorisation holderastrazeneca
    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.3.4Pharmaceutical form Solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROPIVACAINE
    D.3.9.1CAS number 84057-95-4
    D.3.9.4EV Substance CodeSUB10382MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntraperitoneal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    EFECTIVENESS OF ROPIVACAINE 0,1% FOR PAIN CONTROL AFTER LAPAROSCOPIC GYNECOLOGICAL SURGERY
    EFICACIA DE LA ROPIVACAINA 0,1% INTRAPERITONEAL EN EL CONTROL DEL DOOR POSTOPERATORI DE CIRUGIDA LAPAROSCOPICA GINECOLOGICA.
    E.1.1.1Medical condition in easily understood language
    USE OF LOCAL ANESTHESIC INTRAPERITONEAL FOR PAIN CONTROL AFTER LAPAROSCOPIC GYNECOLOGICAL SURGERY
    USO DE LOS ANESTESICOS LOCALES INTRAPERITONEALES EN EL CONTROL DEL DOLOR TRAS CIRUGIA LAPAROSCOPICA GINECOLOGICA.
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    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
    EXTENT OF POSTOPERATIVE PAIN
    CONTROL DEL DOLOR POSTOPERATORIO
    E.2.2Secondary objectives of the trial
    NAUSEA AND VOMITING
    EARLY MOBILIZATION
    PAIN AT SEVENTH DAY
    NAUSEAS Y VOMITOS
    MOBILIZACIÓN PRECOZ
    DOLOR AL SEPTIMO DIA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    FEMALES WHO NEED A GYNECOLOGY LAPAROSCOPIC SURGERY FOR BENING DISEASES
    MUJERES QUE NECESITAN SER SOMETIDAS A UNA CIRUGIA LAPAROSCOPICA POR ENFERMEDAD BENIGNA
    E.4Principal exclusion criteria
    REFUSE TO PARTICIPATE IN THE TRIAL. OVER 2 HOUR OF SURGERY AND ALLERGY TO ANY MEDICATION THAT IT IS USED.
    RECHAZO A PARTICIPAR EN EL ESTUDIO. MÁS DE HORAS DE CIRUGIA O PACIENTES CON ALERGIA ALGÚN MEDICAMENTO QUE SE USA EN EL ESTUDIO.
    E.5 End points
    E.5.1Primary end point(s)
    VISUAL ANALOGIC SCALE
    ESCALA ANALOGICA VISUAL
    E.5.1.1Timepoint(s) of evaluation of this end point
    INMEDIATE POSTOPERATIVE, AT 2,12 AND 24 HOURS
    EN EL POSTOPERATORIO INMEDIATO, A LAS 2, 12 Y 24 HORAS
    E.5.2Secondary end point(s)
    MEDICAL HISTORY
    HISTORIA CLINICA
    E.5.2.1Timepoint(s) of evaluation of this end point
    INMEDIATE POSTOPERATIVE, AT 2,12 AND 24 HOURS
    EN EL POSTOPERATORIO INMEDIATO, A LAS 2, 12 Y 24 HORAS
    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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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
    ULTIMA VISITA DEL ULTIMO 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 months
    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: 60
    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 No
    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 state64
    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)
    TELEPHONE INTERVIEW AFTER A WEEK OF THE SURGERY
    ENTREVISTA TELEFONICA A LA SEMANA DE LA INTERVENCIÓN
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-07
    P. End of Trial
    P.End of Trial StatusOngoing
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