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    The EU Clinical Trials Register currently displays   44043   clinical trials with a EudraCT protocol, of which   7319   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:2007-005181-12
    Sponsor's Protocol Code Number:P070304
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-03-11
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-005181-12
    A.3Full title of the trial
    Analgésie inhalatoire par protoxyde d'azote vs anesthésie locale, pour le recueil ovocytaire en Assistance Médicale à la Procréation. Etude contrôlée, randomisée et prospective
    A.3.2Name or abbreviated title of the trial where available
    KALOVAL
    A.4.1Sponsor's protocol code numberP070304
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    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 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 Kalinox 170 bar
    D.2.1.1.2Name of the Marketing Authorisation holderAir liquide Santé
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameKalinox 170 bar
    D.3.4Pharmaceutical form Inhalation gas
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNmélange équimolaire de protoxyde d'azote et d'oxygène
    D.3.9.3Other descriptive nameKalinox
    D.3.10 Strength
    D.3.10.3Concentration number170 bar
    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.3.11.13.1Other medicinal product typeprotoxyde d'azote 50% et oxygène 50%
    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 Xylocaine 1%
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameXylocaine 1%
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLidocaïne
    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 Xanax
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameXanax
    D.3.4Pharmaceutical form Tablet
    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 INNAlprazolam
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number0,5
    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: 4
    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 Efferalgan codéiné
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameEfferalgan codéiné
    D.3.4Pharmaceutical form Effervescent tablet
    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 INNParacétamol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCodeine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Kalinox utilisé en analgésie lors de ponction ovocytaire en assistance médicale à la procréation.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10003540
    E.1.2Term Assisted fertilization
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objectif principal : Evaluer le bénéfice en terme de douleur d'une analgésie inhalatoire auto-contrôlée par la patiente par protoxyde d'azote 50% de N2O et 50 % d'O2 KALINOX® (Air Liquide, France), comparée au protocole : anesthésie locale associée à un comprimé d'Alprazolam et à un comprimé d'Efferalgan Codéiné®, lors de la ponction ovocytaire.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    o Examen médical préalable
    o Patiente ayant un âge compris entre 18 et 42 ans
    o Patiente incluse dans un protocole de FIV avec ou sans micro-injection et nécessitant une première ponction ovocytaire après stimulation ovarienne par gonadotrophines
    o Patiente ayant donné son consentement éclairé et écrit
    E.4Principal exclusion criteria
    o Contre indication médicale à une anesthésie générale
    o Patiente pusillanime, ou avec de lourds antécédents chirurgicaux
    o Patiente ayant des ovaires d'accès difficile par voie vaginale lors des échographies de monitorage de l'ovulation
    o Refus de la patiente de participer au protocole
    o Patiente ayant une pathologie respiratoire (asthme, BPCO…)
    o Patiente ayant une insuffisance rénale ou hépatique, une immunodépression, un antécédent de cancer, un traitement immunosuppresseur ou une corticothérapie au long cours
    o Patiente non affiliée à un régime de sécurité sociale
    o Contre-indications au protoxyde d'azote
    " Liées à la chirurgie
    ¢ Chirurgie des voies aériennes au bistouri électrique ou au laser: comburant
    ¢ Neurochirurgie en position assise: embolie gazeuse
    ¢ Transplantation hépatique et chirurgie cardiaque sous circulation extra-corporelle: embolie gazeuse
    ¢ Chirurgie ORL: oreille moyenne
    ¢ Chirurgie prolongée > 24 heures
    ¢ Interventions répétées en moins d'une semaine
    " Liées aux patientes
    ¢ Femme enceinte
    ¢ Compliance intracrânienne diminuée
    ¢ Traumatisme thoracique
    ¢ Emphysème pulmonaire
    ¢ Pneumothorax - Emphysème sous-cutané non drainés
    ¢ Insuffisance ventriculaire gauche
    ¢ Maladie de l'oreille moyenne- Perforation de tympan
    ¢ Antécédent de nausées-vomissements
    ¢ Occlusion intestinale
    ¢ Carence en B12-Folates ± Syndrome neuro-anémique
    ¢ Infection sévère + Défaillance multiviscérale + déhiscence de suture
    o Contre-indications à l'Alprazolam
    ¢ Hypersensibilité aux benzodiazépines
    ¢ Hypersensibilité à l'un des composants
    ¢ Syndrome d'apnée du sommeil,
    ¢ Insuffisance respiratoire sévère
    ¢ Insuffisance hépatique sévère
    ¢ Myasthénie
    ¢ Intolérance génétique au galactose
    ¢ Syndrome de malabsorption du glucose et du galactose
    ¢ Déficit en lactase
    o Contre-indications à l'Efferalgan codéiné
    ¢ Hypersensibilité au paracétamol ou aux autres constituants.
    ¢ Insuffisance hépatocellulaire.
    ¢ Insuffisant respiratoire, quel que soit le degré de l'insuffisance respiratoire, en raison de l'effet dépresseur de la codéine sur les centres respiratoires.
    ¢ Asthme.
    ¢ Hypersensibilité à la codéine.
    ¢ Phénylcétonurie.
    o Contre-indications à la lidocaïne
    ¢ Hypersensibilité aux anesthésiques locaux à liaison amide.
    ¢ Porphyries.
    ¢ Épilepsie non contrôlée par le traitement
    Patiente ayant reçu récemment un gaz ophtalmique (SF6, C3F8, C2F6) utilisé dans la chirurgie oculaire tant que persiste une bulle de gaz à l'intérieur de l'oeil et au minimum pendant une période de 3 mois.
    E.5 End points
    E.5.1Primary end point(s)
    Critère d'évaluation principal
    Pourcentage de patientes dont l'EVA (échelle visuelle analogique) (Intensité de la douleur) est = 40 à H+30' (30 min après la ponction d'ovocytes).
    Critères d'évaluation secondaires
    - La douleur :
    " Intensité de la douleur évaluée par l'échelle EVA à H+30', H+60', H+120' (avant sortie),
    " Indice de satisfaction, EVA à H+120',
    " Indice de recommandation de la procédure réalisée, EVA à H+120',
    " Nombre de patientes nécessitant une administration de 1 g de Perfalgan ou de morphinique
    " Nombre de ponctions interrompues pour douleurs.
    - Les paramètres de l'AMP :
    " Nombre d'ovocytes totaux et matures recueillis
    " Nombre d'embryons
    " Qualité embryonnaire,
    " Taux de fécondation,
    " Nombre d'embryons congelés par ponction,
    " Taux de ponctions avec cycle de congélation embryonnaire,
    " Nombre d'embryons transférés,
    " Type d'embryons transférés (J2, ou J3, ou au stade blastocyste),
    " Qualité des embryons transférés,
    " Taux de grossesse biochimique, clinique, et d'implantation embryonnaire.
    - Les critères anesthésiologiques :
    " Pression partielle de CO2 en fin d'expiration (PET CO2),
    " Index bispectral (BIS),
    " Fréquence cardiaque et tension artérielle
    " Comportement de la patiente : agitée, calme,
    " Evènements indésirables ou inopinés,
    " Mécanique de la déglutition : capteurs électromyographiques cutanés (non invasifs).
    - La diffusion des métabolites du Kalinox® dans le liquide folliculaire :
    " Taux de nitrotyrosine protéique dosé par une méthode ELISA (Cayman). Le recueil de liquides folliculaires non hémorragiques macroscopiquement, poolés pour une même patiente sera réalisé en temps réel au laboratoire de médecine de la reproduction. Après recueil de l'ovocyte, chaque liquide est centrifugé (600g) afin d'éliminer les cellules (notamment sanguines), puis chaque liquide de patiente sera aliquoté (500 µl) et congelé en azote liquide puis stocké à -40°C.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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.8.3 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 Information not present in EudraCT
    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 years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    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.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state76
    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 Decision2008-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-23
    P. End of Trial
    P.End of Trial StatusCompleted
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