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    Summary
    EudraCT Number:2016-000486-23
    Sponsor's Protocol Code Number:#01/01.02.2016
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-14
    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 ConcernedFinland - Fimea
    A.2EudraCT number2016-000486-23
    A.3Full title of the trial
    Spinal or epidural fentanyl or sufentanil for labour pain in early phase of the labour
    Spinaalinen tai epiduraalinen fentanyyli tai sufentaniili alkuvaiheen synnytyskivun lievityksessä
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Alleviation of labour pain by epidural or spinal analgetic
    Synnytyskivun lievitys epiduraalisella tai spinaalisella kipulääkkeellä
    A.4.1Sponsor's protocol code number#01/01.02.2016
    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
    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
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelsinki University Central Hospital
    B.5.2Functional name of contact pointKatilo-opiston sairaala/dept of ane
    B.5.3 Address:
    B.5.3.1Street AddressSofianlehdonkatu 5 A
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post code00610
    B.5.3.4CountryFinland
    B.5.4Telephone number358504271850
    B.5.6E-mailantti.vaananen@hus.fi
    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 SUFENTA injektioneste, liuos 5 mikrog/ml
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag 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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpidural use
    Intrathecal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSUFENTANIL CITRATE
    D.3.9.1CAS number 60561-17-3
    D.3.9.4EV Substance CodeSUB04616MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Fentanyl 50 mikrogrammaa/ml
    D.2.1.1.2Name of the Marketing Authorisation holderHameln Pharma Plus GmbH
    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 nameFentanyl 50 mikrogrammaa/ml
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpidural use
    Intrathecal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFentanyl citrate
    D.3.9.1CAS number 990-73-8
    D.3.9.3Other descriptive nameFENTANYL CITRATE
    D.3.9.4EV Substance CodeSUB02129MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(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.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 Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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 labour pain at 20 minutes after intervention
    Synnytyskivun lievitys 20 minuutissa interventiosta
    E.2.2Secondary objectives of the trial
    Duration of the achieved labour pain relief
    Saavutetun synnytyskivunlievityksen kesto
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Primiparous parturients
    In early phase of labour (cervical dilatation at or under 5 cm)
    No prior opioids by any route of administration within past 120 min
    Pain at or over 80 mm on 0-100 mm visual analog scale during contraction
    Ensisynnyttäjiä
    Synnytys ei edennyt yli 5 cm kohdunsuun laajenemisasteelle
    Ei aiempia opioideja 120 minuutin aikana
    Supistuskipu 80 mm tai enemmän 0-100 mm visual analog scalella
    E.4Principal exclusion criteria
    Allergy for any of the medications used
    Contraindications for epidural/spinal analgesia
    BMI at the time of delivery under 20 or over 35 kg/m2
    Allergia mille tahansa tutkittavalle lääkkeelle
    Kontraindikaatio epiduraaliselle/spinaaliselle kivunlievitykselle
    BMI synnytyshetkellä alle 20 tai yli 35 kg/m2
    E.5 End points
    E.5.1Primary end point(s)
    Achieved level of analgesia at 20 minutes after the administration of spinal or epidural analgesia
    Saavutettu kivunlievitys 20 minuutin kohdalla spinaalisen tai epiduraalisen kivunlievityksen annon jälkeen
    E.5.1.1Timepoint(s) of evaluation of this end point
    20 minutes after administration of analgesia
    20 minuuttia kivunlievityksen annosta
    E.5.2Secondary end point(s)
    The duration of achieved analgesia in minutes
    Time from spinal/epidural analgesia to delivery
    Saavutetun kivunlievityksen kesto
    Aika kivunlievityksen annosta synnytykseen
    E.5.2.1Timepoint(s) of evaluation of this end point
    Estimated to be within 5-8 hours after administration of the study drug spinally or epidurally
    Arviolta 5-8 tunnin kuluttua tutkimuslääkkeen spinaalisesta tai epiduraalisesta annoselusta
    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 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.8.2.4Number of treatment arms in the trial4
    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
    The delivery of the child of the last parturient in the study
    Viimeisen tutkimukseen osallistuvan synnyttäjän lapsen syntymä
    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: 80
    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 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 state80
    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)
    Normal treatment according to in-house protocol for labour pain by epidural boluses using the epidural catheter that is placed in the lumbar epidural space as part of the trial.
    Normaali synnytyskivun hoito epiduraalisin bolus annoksin käyttäen tutkimuksen yhteydessä lannerangan alueelle asennettua epiduraalikatetria.
    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 Decision2016-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-31
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