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    Summary
    EudraCT Number:2013-005114-35
    Sponsor's Protocol Code Number:KETAPLAST201300511435
    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:2014-03-04
    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 number2013-005114-35
    A.3Full title of the trial
    Administration of S-ketamine for negative pressure wound therapy dressing change associated pain: a randomized, prospective, placebo-controlled cross-over study
    S-ketamiini alipaineimulaitteen sidevaihdon aiheuttaman toimenpidekivun hoidossa: randomoitu, prospektiivinen, lumekontrolloitu cross-over tutkimus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    S-Ketamine to reduce pain associated with negative pressure wound therapy dressing change
    S-ketamiini haavan alipaineimulaitteen sidevaihdon aiheuttaman kivun hoidossa
    A.4.1Sponsor's protocol code numberKETAPLAST201300511435
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN90985804
    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 Hospital
    B.5.2Functional name of contact pointJorvi Hospital
    B.5.3 Address:
    B.5.3.1Street AddressTuruntie 150
    B.5.3.2Town/ cityHelsinki HUS
    B.5.3.3Post code00029
    B.5.3.4CountryFinland
    B.5.4Telephone number+35894711
    B.5.6E-mailvesa.kontinen@hus.fi
    B.Sponsor: 2
    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 pointTöölö Hospital
    B.5.3 Address:
    B.5.3.1Street AddressTopeliuksenkatu 5 PB 266
    B.5.3.2Town/ cityHelsinki HUS
    B.5.3.3Post code00029
    B.5.3.4CountryFinland
    B.5.4Telephone number+35894711
    B.5.6E-mailvesa.kontinen@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 Ketanest-S
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer 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 nameKetanest-S
    D.3.4Pharmaceutical form Injection
    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 INNESKETAMINE HYDROCHLORIDE
    D.3.9.3Other descriptive nameESKETAMINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB25811
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    adult patients undergoing negative pressure wound therapy dressing change
    alipaineimulaitteen sidevaihtoon tulevia aikuispotilaita
    E.1.1.1Medical condition in easily understood language
    adult patients undergoing negative pressure wound therapy dressing change
    alipaineimulaitteen sidevaihtoon tulevia aikuispotilaita
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10074212
    E.1.2Term Vacuum assisted wound closure
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to reduce pain and the need of rescue fentanyl during negative pressure wound therapy dressing change associated pain
    haavan alipaineimuliatteen sidevaihtoon liittyvön kivun ja lisäkipulääkityksen tarpeen vähentäminen
    E.2.2Secondary objectives of the trial
    evaluating haemodynamic changes and possible confusion
    hemodynaamisten muutosten ja mahdollisen sekavuuden esiintymisen arviointi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    adult patients undergoing negative pressure wound therapy dressing change
    haavan alipaineimulaitehoitoon kuuluvaan sidevaihtoon tulevia aikuispostilaita
    E.4Principal exclusion criteria
    BMI >40, ischemic cardiac disease, increased intracranial pressure, increased intraocular pressure, graviidity, lactation, hypersensitivity or allegy to ketamine, fentanyl or midazolam, severe psychiatric disease, drug addiction, unability to use NRS-pain scale
    BMI >40, iskeeminen sydänsairaus, kohonnut kallon- tai silmänsisäinen paine, raskaus, imetys, yliherkkyys, ketamiinille, fentanyylille tai midatsolaamille, vakava psykiatrinen sairaus, päihderiippuvuus, kyvyttömyys käyttää NRS-kivunmittausmenetelmää
    E.5 End points
    E.5.1Primary end point(s)
    pain during negative pressure wound therapy dressing change, the need of rescue fentanyl (an opiodi) during the procedure)
    toimenpiteen aikainen kipu, lisäkipulääkkeen (fentanyyli) tarve
    E.5.1.1Timepoint(s) of evaluation of this end point
    pain at the beginning of the procedure and at 15 minutes, 30 minutes, 45 minutes and 60 minutes, after 3 months
    kipu ennen toimenpidettä, 15min. , 30 min., 45 min. ja 60 min. kohdalla toimenpiteestä sekä 3 kk kuluttua.
    E.5.2Secondary end point(s)
    evaluation of hemodynamic changes /heart rate, blood pressure) and oxygen saturation, evaluation of confusion
    hemodynaamisten muuttujien ja happisaturaation sekä sekavuuden esiintymisen arviointi
    E.5.2.1Timepoint(s) of evaluation of this end point
    15, 30, 45 and 60 minutes for RR, p, Sp02
    15 and 60 minutes for confusion using RASS-scale (Richmond Agitation Sedation scale)
    sykkeen, verenpaineen ja happisaturaation mitatus 15min, 30min, 45min ja 60 min kohdalla
    Sekavuuden arviointi 15min ja 60 min kohdalla käyttäen RASS-asteikkoa (Rinchmond Agitation Sedation Scale)
    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 No
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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
    3 months after the procedure
    Toimenpiteen jälkeen 3 kk kohdalla kun potilaalle soitetana ja kysytään senhetkisen kivun esiintymisestä toimenpitealueella
    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 months3
    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: 23
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 Yes
    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 state23
    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)
    not different from expected normal treatment of this condition
    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 Decision2014-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-12
    P. End of Trial
    P.End of Trial StatusOngoing
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