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    Summary
    EudraCT Number:2012-000747-26
    Sponsor's Protocol Code Number:KETTO201200047426
    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:2012-04-02
    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 number2012-000747-26
    A.3Full title of the trial
    Administration of S-Ketamine during spinal surgery to reduce postoperative pain
    S- Ketamiinin annostelu selkäleikkauksen aikana leikkauksenjälkeisen kivun vähentämiseksi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ketamine to reduce postoperative pain in back surgery
    Ketamiini selkäleikkauksessa leikkauksenjälkeisen kivun vähentämiseksi
    A.4.1Sponsor's protocol code numberKETTO201200047426
    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 Universiy 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 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 pointKipuklinikka
    B.5.3 Address:
    B.5.3.1Street AddressHaartmaninkatu 2A
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post code00029 HUS
    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.3.9.1CAS number 33643-46-8
    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 Placebo: 2
    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 spinal surgery
    selkäleikkaukseen tulevia aikuispotilaita
    E.1.1.1Medical condition in easily understood language
    adult patients undergoing back surgery
    selkäleikkaukseen 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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10041595
    E.1.2Term Spinal stenosis lumbar
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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 the need of opioids after surgery
    leikkauksenjälkeisen opioiditarpeen vähentäminen
    E.2.2Secondary objectives of the trial
    to reduce postoperative confusion, pain, depression
    Toissijaisina muuttujina tarkastellaan ketamiinista mahdollisesti johtuvan sekavuuden esiintymistä heräämössä, selvitetään potilaiden kokeman kivun intensiteettiä ja selvitetään potilaiden mielialaa ennen leikkausta ja jälkitarkastuksen yhteydessä. Lisäksi analysoidaan, vaikuttaako eri ketamiiniannokset mahdollisen sekavuuden esiintymiseen ja tiedolliseen suorituskykyyn eri ikäryhmissä.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult patients undergoing elective posterior lumbar fusion surgery volunteering for the study.
    Tutkimukseen otetaan halukkaat yli 18-vuotiaat potilaat, jotka tulevat elektiiviseen lannerangan posterioriseen luudutusleikkaukseen (toimenpidekoodit NAG62, NAG63 ja NAG66)
    E.4Principal exclusion criteria
    BMI>35, unstable ischaemic cardiac disease, increased intracranial pressure, increased intraocular pressure, gravidity, lactation, hypersensitivity or allergy to ketamine, oxycodone, propofol or remifentanil, severe psychiatric disease, unwillingness or unability to use PCA-device, unability to use NRS-pain scale
    Poissulkukriteereinä tutkimukseen osallistumiselle on painoindeksi (BMI, body mass index) yli 35, epästabiili iskeeminen sydänsairaus, kohonnut kallonsisäinen paine, aikaisemmin todettu kohonnut silmänpaine, raskaus, imetys, yliherkkyys ketamiinille, oksikodonille, propofolille tai remifentaniilille, vakava psykiatrinen sairaus, potilaan kyvyttömyys tai haluttomuus käyttää PCA-pumppua (patient-controlled analgesia, kipupumppu, josta potilas itse annostelee kipulääkityksensä) leikkauksenjälkeisessä kivunhoidossa sekä kyvyttömyys käyttää NRS (numerical rating scale) –kivunmittausmenetelmää.
    E.5 End points
    E.5.1Primary end point(s)
    consumption of oxycodone with PCA-device 48 hours after the surgery
    oksikodonin tarve PCA-laitteella 48 tuntia leikkauksen jälkeen
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours after the surgery
    48 tuntia leikkauksen jälkeen
    E.5.2Secondary end point(s)
    confusion in the postoperative care unit, pain,
    depression
    ketamiinista mahdollisesti johtuvan sekavuuden esiintymistä heräämössä, selvitetään potilaiden kokeman kivun intensiteettiä ja selvitetään potilaiden mielialaa ennen leikkausta ja jälkitarkastuksen yhteydessä. Lisäksi analysoidaan, vaikuttaako eri ketamiiniannokset mahdollisen sekavuuden esiintymiseen ja tiedolliseen suorituskykyyn eri ikäryhmissä.
    E.5.2.1Timepoint(s) of evaluation of this end point
    confusion in the postoperative care unit approximately 4 hours
    pain 48 hours after surgery, 3 months after surgery and 24 after surgery
    depression before surgery and 3 months after surgery
    sekavuus -heräämövaihe n. 4 tuntia
    kipu 48 tuntia leikkauksen jälkeen, 3 kuukauden kohdalla ja 24 kuukauden kohdalla
    mieliala ennen leikkausta ja 3 kuukauden kohdalla
    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 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) 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
    Last visit of the subject undergoing the trial
    Selkäleikkauspotilaan hoitoprotokollaan kuuluva kontrollikäynti 2 v leikkauksen 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: 192
    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 state192
    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 Decision2012-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-15
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