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    Summary
    EudraCT Number:2016-001373-33
    Sponsor's Protocol Code Number:2016-3
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-08-15
    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 ConcernedSweden - MPA
    A.2EudraCT number2016-001373-33
    A.3Full title of the trial
    Clinical Study Protocol
    An open phase IV,RCT, evaluating patient controlled sedation, in three different dosages of propofol in healthy subjects undergoing elective gynaecological out-patient surgery in local anaesthesia.
    Klinisk studie Protocol
    En randomiserad kontrollerad öppen studie för att utvärdera patientkontrollerad sedering i tre olika doser till friska patienter som genomgår planerad gyneokologisk dagkirurgisk operation i lokalanestesi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study protocol for patient inout-patient surgery on local anaesthetic and self controlled sedation (PCS) with propofol in three different concentrations per dose (PROP-3). The study is a comparison of three different dose levels of propofol .
    Studie protokoll för en studie på patienter i dagkirurgiska ingrepp i lokalbedövning och samtidig patientstyrd avslappnande medicinering med propofol. Studien är en jämförelse mellan tre olika dosnivåer av propofol.
    A.3.2Name or abbreviated title of the trial where available
    PROP-3
    PROP-3
    A.4.1Sponsor's protocol code number2016-3
    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 SponsorRegion Ostergotland
    B.1.3.4CountrySweden
    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 supportRegion Ostergotland
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegion Ostergotland
    B.5.2Functional name of contact pointANOPIVA
    B.5.3 Address:
    B.5.3.1Street AddressUniversitetssjukhuset
    B.5.3.2Town/ cityLinköping
    B.5.3.3Post code58185
    B.5.3.4CountrySweden
    B.5.4Telephone number+460101031835
    B.5.6E-mailchristina.eintrei@liu.se
    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 Propofol-Lipuro 5mg/mL
    D.2.1.1.2Name of the Marketing Authorisation holderB Braun Melsungen AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namePropofol
    D.3.4Pharmaceutical form Emulsion for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPropofol
    D.3.9.3Other descriptive namePROPOFOL
    D.3.9.4EV Substance CodeSUB10116MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.04 to 0.08
    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
    Gynecological outpatient surgery
    Gynekologiska ingrepp i dagkirurgi
    E.1.1.1Medical condition in easily understood language
    Gynecological outpatient surgery
    Gynekologiska ingrepp i dagkirurgi
    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
    Identifying the most optimal dose of propofol without opioids to reduce risk for depressed respiration( oxigen - saturation) while maintaining adequate moderate sedation ( EEG and response to verbal command ) and comfort with patient-controlled sedation( need of alfentanil/ propofol).
    Identifiera den mest optimala propofoldos utan tillägg av opioider, för måttlig sedering ( EEG och svar på uppmaning) utan risk för andningspåverkan (syremättnad) smärta och obehag( behov av alfentanil/ prpofol).
    E.2.2Secondary objectives of the trial
    Concentration of propofol in plasma
    Patient satisfaction and recovery
    Koncentation av propofol i plasma
    Patienttillfredsställelse och återhämtning
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Obtained Inform Consent
    Healthy women ASA classification I-II
    Age 50-70 years, kakuasier
    BMI 20-30
    Elective outpatient gynecological procedures
    Inhämtat samtycke
    Friska kvinnor ASA klassificering I-II
    Ålder 50-70 år, kakuasier
    BMI 20-30
    Elektiva polikliniska gynekologiska ingrepp
    E.4Principal exclusion criteria
    Psyciatric disorder
    Use of Antipsycotics, Sedatives, Opioids
    Smoking
    Allergy to propofol
    Abuse of drugs and alcohol
    Incapable of giving consent
    Chronic pelvic pain
    Positive pregnancy test , measured in woman with childbearing potential















    Smoking
    Allergy to propofol
    Abuse of drugs and alcohol
    Incapable of giving consent
    Psykiatrisk sjukdom
    Bruk av anipsykofarmaka,sedativa eller opiatiska läkemedel
    Rökning
    Allergi mot propofol
    Missbruk av droger och alkohol
    Oförmögen att lämna samtycke
    Kronisk bäckensmärta
    Positiv graviditetstest , mätt på kvinnor med möjlighet att bli gravid
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the risk of depressed respiration in different dosage of propofol administrated as patient controlled sedation. Depressed respiration defined as oxygen saturation below 94%
    To evaluate level of pain Using NRS defined as 3 or more before surgery and every five minutes or if patient verbalises pain during surgery
    To evaluate EEG pattern during patient controlled sedation
    To evaluate need of rescue medication, alfentanil and/ or propofol
    Att identifiera risken för andningsdepression vid olika doser av propofol där patienten använder sig av själv kontrollerad sedering. Andningsdepression definieras som saturation <94%
    Att utvärdera smärtnivån med hjälp av NRS definerad som smärta >3 innan eller under kirurgin eller om patienten spontant ger uttryck för smärta
    Att utvärdera EEG mönstret i samband med patientkontrollerad sedering
    Att utvärdera behov av extra medicinering I form av alfentanil och eller extra propofol
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuous measurement of respiratory rate for 15-90 minutes depending on the operating length
    Continuous measuring of puls saturation
    NRS registration every five minutes
    Kontinuerlig mätning av andningsfrekvens under 15-90 minuter beroende på operationslängd
    Kontinuerlig mätning av puls saturation
    Registrering av NRS var femte minut
    E.5.2Secondary end point(s)
    To evaluate the plasma concentration of propofol at certain time points
    To evaluate patient satisfaction with self controlled sedation
    To evaluate the surgeons opinion of procedure feasibillity
    Att fastställa plasma concentration av propofol vid särskilda tidpunkter
    att utvärdera patientens tillfredställelse med patient kontrollerad sedering
    Att utvärdera kirurgens åsikt om metoden utifrån möjlighet till åtkomst och möjlighet till att arbeta patientsäkert
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continuously during the surgery with EEG.
    Patient satisfaction control one hour after the end of surgery, and telephone follow-up after 48 hours
    Surgeons satisfaction direct after surgery
    Kontinuerligt under operationen med EEG.
    Patienttillfredsställelse en timma efter ingreppets slut och telefonuppföljning efter 48 timmar
    Kirurgens åsikt om sederingsmetoden direct efter ingreppet
    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 Yes
    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 No
    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 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) No
    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 Yes
    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 Spring 2019
    LSLV våren 2019
    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 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: 90
    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 state120
    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)
    Last day in study is the follow-up phone call day two after surgery
    Siata dag i studien för varje studiedeltagare är ett telefonuppföljningssamtal två dagar efter operationen
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Kvinnokliniken Linköpings Universitetssjukhus
    G.4.3.4Network Country Sweden
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-27
    P. End of Trial
    P.End of Trial StatusOngoing
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