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    Summary
    EudraCT Number:2016-002374-12
    Sponsor's Protocol Code Number:v2_29.05.2016
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-10-25
    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 ConcernedFinland - Fimea
    A.2EudraCT number2016-002374-12
    A.3Full title of the trial
    Oxycodone compared to meperidine in the treatment of labour pain
    Oksikodoni verrattuna petidiiniin synnytyskivun hoidossa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Oxycodone compared to meperidine in the treatment of labour pain
    Oksikodoni verrattuna petidiiniin synnytyskivun hoidossa
    A.4.1Sponsor's protocol code numberv2_29.05.2016
    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 SponsorHelsinki University Central Hospital/ Women's hospital
    B.1.3.4CountryFinland
    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 supportHelsinki University Central Hospital/Women's hospital
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr Jouni Ahonen
    B.5.2Functional name of contact pointHUCH/Kätilöopiston sairaala
    B.5.3 Address:
    B.5.3.1Street AddressSofianlehdonkatu 5 A
    B.5.3.2Town/ cityHelsinki/HUS
    B.5.3.3Post code00029
    B.5.3.4CountryFinland
    B.5.4Telephone number358504271852
    B.5.6E-mailjouni.ahonen@hus.fi
    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.2.1.1.1Trade name Petidin meda 50 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderUnimedic AB
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 namePetidin meda 50 mg/ml
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPETHIDINE
    D.3.9.1CAS number 57-42-1
    D.3.9.4EV Substance CodeSUB09738MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Oxanest 10 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Oy
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameOxanest 10 mg/ml
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYCODONE
    D.3.9.1CAS number 76-42-6
    D.3.9.4EV Substance CodeSUB09562MIG
    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
    Labour pain
    Synnytyskipu
    E.1.1.1Medical condition in easily understood language
    Labour pain
    Synnytyskipu
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10023554
    E.1.2Term Labour pains stopped
    E.1.2System Organ Class 100000004868
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Alleviation of uterine contraction associated intensity of labour pain in the early phase of labour
    Supistuskivun voimakkuuden lievitys synnytyksen alkuvaiheessa
    E.2.2Secondary objectives of the trial
    Time delay from administration of IMP to request for next analgesia (epidural analgesia)
    Aika siihen kun synnyttäjä haluaa lisäkivunlievitystä (kuten epiduraalipuudutuksen)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Previously healthy primiparous parturients, who
    volunteer to participate in the study and who
    have normal fetal heart rate and who
    have planned to take epidural or other regional anesthesia for labour pain
    Aiemmin terveitä ensisynnyttäjiä, jotka
    ovat vapaaehtoisia osallistumaan tutkimukseen ja joilla
    on normaali sikiön sykekäyrä ja jotka
    ovat suunnitelleet ottavansa selkäpuudutuksen tai muun puudutuksen synnytyskivunlievitykseen
    E.4Principal exclusion criteria
    Age under 18 or over 45
    Obesity BMI over 35,
    Diabetes with insulin, epilepsy, liver or kidney disease
    Complicated pregnancy (such as pre-eclampsia or hepatogestosis)
    Use of medication which could alter the pharmacokinetics of the studied drugs
    Abnormal heart rate of fetus (CTG)
    Green amniotic fluid
    Small size of the fetus for the gestation age
    Reduced motility of the fetus
    Abnormal flow in the umbilical vessels
    Ikä yli 45 v tai alle 18 v
    Obesiteetti, BMI yli 35
    MErkitävä perussairaus, kuten insuliinihoitoinen diabeted, epilepsia tai maksan tai munuaisten toiminnan häiriö
    Komplisoitunut raskaus (pre-eklampsia, hepatogestoosi)
    Synnyttäjällä käytössä lääkitys joka voi vaikuttaa oksikodonin farmakokinetiikkaan
    Sikiön poikkeava sykekäyrä (KTG)
    Vihreä lapsivesi
    SIkiön kasvuhidastuma
    VÄhentyneet sikiön liikkeet
    KAikukuvauksella todettu poikkeava napasuonten virtauslöydös
    E.5 End points
    E.5.1Primary end point(s)
    Request for additional analgesia for labour pain following the administration of IMP
    Synnyttäjän pyytäessä lisäkivunlievitystä tutkimuslääkkeen annon jälkeen
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 2-4 hours after administration of IMP
    Noin 2-4 tuntia tutkimuslääkkeen annostelun jälkeen
    E.5.2Secondary end point(s)
    Mode of delivery, apgar score of the infant
    Synnytystapa, syntyneen lapsen apgar pisteet
    E.5.2.1Timepoint(s) of evaluation of this end point
    Less than 24 hrs after administration of IMP
    Alle 24 h tutkimuslääkkeen annon jälkeen
    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 No
    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
    When the last parturient in the study requests for additional analgesia following IMP administration
    Kun viimeinen tutkimukseen osallistuva synnyttäjä pyytää lisäkivunlievitystä tutkimusvalmisteen annon jälkeen.
    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 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) 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 No
    F.3.3Specific vulnerable populations Yes
    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 Yes
    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 state60
    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)
    Standard epidural or other regional analgesia for labour pain.
    Normaali epiduraalinen tai muu puudutus synnytyskivun hoitamiseksi
    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 Decision2016-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-24
    P. End of Trial
    P.End of Trial StatusOngoing
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