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    Summary
    EudraCT Number:2013-005426-30
    Sponsor's Protocol Code Number:HISTEROSCOPIA-2013
    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:2014-02-18
    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 number2013-005426-30
    A.3Full title of the trial
    USE OF NITROUS OXIDE FOR PAIN RELIEF IN DIFFERENT HISTEROSCOPY PROCEDURES
    UTILIZACIÓN DE ÓXIDO NITROSO PARA ALIVIO DEL DOLOR EN LOS DISTINTOS PROCEDIMIENTOS HISTEROSCÓPICOS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    USE OF THE ANESTHETIC NITROUS OXIDE FOR PAIN RELIEF IN DIFFERENT PROCEDURES IN GYNECOLOGY
    USO DEL ANESTÉSICO ÓXIDO NITROSO PARA EL ALIVIO DEL DOLOR EN LOS DIFERENTES PROCEDIMIENTOS EN GINECOLOGÍA
    A.4.1Sponsor's protocol code numberHISTEROSCOPIA-2013
    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 SponsorFUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSITARIO PRINCIPE DE ASTURIAS
    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 supportAIR LIQUIDE SANTE INTERNATIONAL
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundacion para la Investigación Biomedica del Hospital Universitario Principe de Asturias
    B.5.2Functional name of contact pointFarmacologia Clinica
    B.5.3 Address:
    B.5.3.1Street AddressCarretera Alcala-Meco s/n
    B.5.3.2Town/ cityAlcala de Henares
    B.5.3.3Post code28805
    B.5.3.4CountrySpain
    B.5.4Telephone number+349188781002610
    B.5.5Fax number+34918822674
    B.5.6E-mailantonio.hupa@gmail.com
    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 Kalinox
    D.2.1.1.2Name of the Marketing Authorisation holderAir Liquide Santé International
    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 nameNitrous Oxide 50% - Oxygen 50%
    D.3.4Pharmaceutical form Medicinal gas, compressed
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKalinox
    D.3.9.1CAS number 10024-97-2
    D.3.9.3Other descriptive nameNITROUS OXIDE
    D.3.9.4EV Substance CodeSUB03447MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYGEN
    D.3.9.3Other descriptive nameKalinox
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Lidocaina normon 10mg/ml solucion inyectable EFG
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Normon S.A.
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEndocervical use
    Intrauterine use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLidocaina normon 10mg/ml solucion inyectable EFG
    D.3.9.3Other descriptive nameLIDOCAINE
    D.3.9.4EV Substance CodeSUB08507MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 associated to hysteroscopy procedures
    Dolor asociado a procedimientos histeroscópicos
    E.1.1.1Medical condition in easily understood language
    Pain
    Dolor
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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 assess whether equimolar mixture of oxygen and nitrous oxide (Kalinox ®) has a greater effect on pain control during hysteroscopy compared with paracervical local anesthesia with lidocaine 1% and with no analgesic treatment, with a difference of 30 points or more, as measured by the visual analog scale (VAS), in the mean perceived pain during hysteroscopy.
    Evaluar si la mezcla equimolar de oxígeno y óxido nitroso (Kalinox®) tiene una mayor efecto en el control del dolor durante la histeroscopia, comparada con la anestesia local paracervical con lidocaína al 1% y con el no tratamiento analgésico, con una diferencia de 30 puntos o más, medida mediante la escala visual analógica (EVA), en la media del dolor percibido durante la histeroscopia.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of the equimolar mixture of oxygen and nitrous oxide 50% during diagnostic hysteroscopy compared with paracervical local anesthesia with lidocaine 1 % and the control group without analgesic treatment.
    - Assess patient satisfaction with the procedure.
    - Perception of pain by the investigator in the different methods of analgesia
    - Match the analgesic effect of each treatment during hysteroscopy with procedures determined by the different variables such as : hysteroscopy indication , duration of procedure , techniques performed ( diagnostic hysteroscopy / polypectomy / insertion of Essure device), hysteroscopic findings and complications produced .
    - Compare the vital signs of each patient before, during and after the procedure with different types of analgesia.
    - Assess the impact of medical and socio-cultural variables that influence the analgesic effect.
    - Evaluar la seguridad y tolerabilidad de la mezcla equimolar de oxígeno y óxido nitroso al 50% durante la histeroscopia diagnóstica, comparándolo con la anestesia local paracervical con lidocaína al 1% y el grupo control sin tratamiento analgésico.
    - Evaluar la satisfacción de las pacientes con el procedimiento.
    - Percepción del dolor por el investigador en los diferentes métodos de analgesia
    - Relacionar el efecto analgésico de cada tratamiento durante la histeroscopia con variables determinadas por los diferentes procedimientos como: indicación de la histeroscopia, duración del procedimiento, técnicas realizadas (histeroscopia diagnóstica/ polipectomía/ inserción de dispositivo Essure), hallazgos histeroscópicos y complicaciones producidas.
    - Comparar las constantes vitales de cada paciente antes, durante y después del procedimiento con los diferentes tipos de analgesia.
    - Evaluar la influencia de las variables médicas y socioculturales que influyen en el efecto analgésico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Women over 18 years.
    - Patients candidates for conducting hysteroscopy, referred from the gynecology clinics.
    - Mujeres mayores de 18 años.
    - Pacientes candidatas a realización de histeroscopia en sala de pruebas especiales, remitidas desde las consultas de ginecología.
    E.4Principal exclusion criteria
    - Patients with allergies or contraindications to the study drugs.
    - Deficiency of vitamin B12 or folic acid documented and untreated.
    - Neurological abnormalities unexplained and recent onset.
    - Patients who are pregnant or who might become pregnant.
    - Women breastfeeding.
    - Patients treated with other depressants of the central nervous system such as opiates, benzodiazepines and other psychotropic drugs.
    - Patients not fluent in Spanish language.
    - Inability to grant informed consent.
    - Pacientes con alergias o contraindicaciones a los medicamentos del estudio.
    - Deficiencia de vitamina B12 o ácido fólico documentada y no tratada.
    - Anomalías neurológicas inexplicadas de comienzo reciente.
    - Pacientes embarazadas o que pudieran estarlo.
    - Mujeres en periodo de lactancia.
    - Pacientes en tratamiento con otros fármacos depresores del sistema nervioso central como opiáceos, benzodiazepinas y otros psicotrópicos.
    - Pacientes que no manejen con fluidez el castellano.
    - Incapacidad para otorgar el consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    Pain felt during the histeroscopy procedure measured by the visual analog scale (VAS) within a range of 0 to 100 where 0 is no pain at all and 100 is the most intense pain felt ever.
    Dolor sentido durante el procedimiento histeroscópico medio por una escala analógia visual de 0 a 100, donde 0 0 es nada de dolor y 100 el máximo dolor posible.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The different histeroscopy procedures last 10 minutes in average
    Los procedimientos histeroscópicos duran una media de 10 minutos.
    E.5.2Secondary end point(s)
    Safety and tolerability
    Satisfaction level with the technique
    Pain felt by the patient perceived by the investigator
    To evaluate the analgesic effects related to the different indications of the histeroscopy.
    To compare de vital signs before, during and after the procedure.
    To assess the sociocultural and medical conditions with the analgesic effect.
    Seguridad y tolerabilidad
    Nivel de satisfacción con la técnica
    Percepción del dolor sufrido por la paciente por el investigador
    Evaluar el efecto analgésico relacionado con los diferentes procedimientos histeroscópicos.
    Comparar las constantes vitales antes, durante y después de la realización del procedimiento.
    Evaluar las condiciones médicas y socioculturales que influyen en el efecto analgésico.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the histeroscopy procedure and the day after via telephone contact.
    El día de la realización de la histeroscopia y al día siguiente mediante contacto telefónico.
    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 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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Evaluacion enmascarada por terceros
    With blind assessment by third parties
    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
    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 years
    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: 297
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state297
    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)
    Expected normal treatment for each condition
    Según práctica clínica habitual
    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 Decision2014-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-03
    P. End of Trial
    P.End of Trial StatusCompleted
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