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    The EU Clinical Trials Register currently displays   43931   clinical trials with a EudraCT protocol, of which   7307   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-001714-29
    Sponsor's Protocol Code Number:290975
    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:2017-06-14
    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 number2017-001714-29
    A.3Full title of the trial
    Influence of epidural analgesia on opioid consumption and patients recovery after laparoskopic colorectal surgery.
    Epiduraalipuudutuksen vaikutus opiodikipulääkkeiden tarpeeseen ja potilaiden toipumiseen laparoskooppisen kolon-kirurgian jälkeen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Influence of epidural analgesia on opioid consumption and patients recovery after bowel surgery.
    A.3.2Name or abbreviated title of the trial where available
    EPRAL
    A.4.1Sponsor's protocol code number290975
    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 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 supportNo
    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 pointAlexey Schramko
    B.5.3 Address:
    B.5.3.1Street AddressTuruntie 150
    B.5.3.2Town/ cityJorvi
    B.5.3.3Post code00029 HUS
    B.5.3.4CountryFinland
    B.5.4Telephone number+358504270610
    B.5.6E-mailaschramko@hotmail.com
    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 Ropivacain Orion 2 mg/ml inf. liuos
    D.2.1.1.2Name of the Marketing Authorisation holderOrion
    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 nameRopivacain Orion 2 mg/ml inf. liuos
    D.3.2Product code N01BB09
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpidural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROPIVACAINE HYDROCHLORIDE
    D.3.9.3Other descriptive nameROPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04264MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Compare epidural and conventional pain treatment after laparoskopic colorectal surgery.
    Tutkimuksen tavoitteena on verrata epiduraalipuudutusta ja perinteistä kivun hoitoa kolonkirurgisten potilaiden postoperatiivisessa toipumisessa.
    E.1.1.1Medical condition in easily understood language
    Compare epidural and conventional pain treatment after laparoskopic colorectal surgery.
    Tutkimuksen tavoitteena on verrata epiduraalipuudutusta ja perinteistä kivun hoitoa kolonkirurgisten potilaiden postoperatiivisessa toipumisessa.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    Primary outcome is the opioid consumption 48h postoperatively.
    Ensisijainen lopputulosmuuttuja on ryhmien välinen ero opioidin kulutuksessa 0- 48 tuntia leikkauksen jälkeen.
    E.2.2Secondary objectives of the trial
    Secondary outcomes: pain intensity, initiation of the bowel action, intraoperative fluid balance, postoperative complications, ward-stay time. Additionally, we will compare the efficacy of pain treatments in two subgroups: left- and right hemicolonectomy.
    Sekundaariset lopputulosmuuttujat ovat kipu NRS-asteikolla, potilaiden postoperatiivinen suoliston toiminnan käynnistyminen (monenako postoperatiivisena päivänä leikkauksen jälkeen) intraoperatiivinen nestetasapaino, postoperatiiviset komplikaatiot (kliinisesti todettu leikkaushaavan infektio, leikkauksen jälkeinen keuhkokuume, suoliiskemia, uusintaleikkaus saman hoitojakson aikana, sairaala re-admissio), sekä sairaalassaoloaika (monenako postoperatiivisena päivän potilas on lähtenyt kotiin). Lisäksi tutkimuksen etukäteen suunnitellussa alaryhmäanalyysissä verrataan epiduraalihoidon tehokkuutta vasemman- ja oikeanpuolisella hemikolektomia potilailla.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Laparoskopic colorectal surgery, informed consent given.
    Inkluusiokriteerit: kolonkirurgiset potilaat, joille on suunniteltu elektiivinen laparoskooppinenn oikeapuolinen hemikolektomia, ileokekaalinen resektio, vasemmanpuolinen hemikolektomia tai sigmasuolen resektio ja jotka ovat halukkaita osallistumaan tutkimukseen saatuaan siitä tietoa (informed concent).
    E.4Principal exclusion criteria
    Severe renal, hepatic insufficiency, severe COPD, cancer T4, hematological disease, preoperative use of opioids, coagulation disturbances or any impossibility to put epidural catheter, over 50% risk of surgery conversion.
    Ekskluusiokriteerit: vaikea munuaisten vajaatoiminta (GFR ≤ 30 ml/min), vaikea maksan vajaatoiminta (TT ≤ 50%), vaikea keuhkoahtaumatauti (FEV1 alle 30%), levinnyt syöpä (T4), hematologinen sairaus, preoperatiivinen opioidikäyttö, synnynnäinen tai muu hyytymishäiriö tai jokin muu este epiduraalikatetrin laittamiselle. Jos konversioriski (riski tähystysleikkauksen muuttumisesta avoleikkaukseksi) on arvioitu preoperatiivisesti olevan yli 50% tai muusta syystä hoitava anestesialääkäri katsoo epiduraalipuudutuksen olevan tärkeä potilaan kivun hoidossa, ei potilasta oteta tutkimukseen, jotta epiduraalikatetrin laittamisesta voidaan päättää ilman satunnaistamista. Potilaita, jotka eivät halua epiduraalikatetria, ei voida myöskään ottaa mukaan tutkimukseen.
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome is the opioid consumption 48h postoperatively.
    Ensisijainen lopputulosmuuttuja on ryhmien välinen ero opioidin kulutuksessa 0- 48 tuntia leikkauksen jälkeen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48h and 3 month after surgery.
    48h leikkauksesta sekä 3kk leikkauksesta.
    E.5.2Secondary end point(s)
    Secondary outcomes: pain intensity, initiation of the bowel action, intraoperative fluid balance, postoperative complications, ward-stay time. Additionally, we will compare the efficacy of pain treatments in two subgroups: left- and right hemicolonectomy.
    Sekundaariset lopputulosmuuttujat ovat kipu NRS-asteikolla, potilaiden postoperatiivinen suoliston toiminnan käynnistyminen (monenako postoperatiivisena päivänä leikkauksen jälkeen) intraoperatiivinen nestetasapaino, postoperatiiviset komplikaatiot (kliinisesti todettu leikkaushaavan infektio, leikkauksen jälkeinen keuhkokuume, suoliiskemia, uusintaleikkaus saman hoitojakson aikana, sairaala re-admissio), sekä sairaalassaoloaika (monenako postoperatiivisena päivän potilas on lähtenyt kotiin). Lisäksi tutkimuksen etukäteen suunnitellussa alaryhmäanalyysissä verrataan epiduraalihoidon tehokkuutta vasemman- ja oikeanpuolisella hemikolektomia potilailla.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 month
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 Yes
    E.8.2.3.1Comparator description
    Conventional pain treatment: paracetamol and regional anesthesia with 3.75-5% Ropivacain
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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
    Yes
    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 months5
    E.8.9.1In the Member State concerned days0
    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: 70
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-06-14. Yes
    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 state160
    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)
    None.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-22
    P. End of Trial
    P.End of Trial StatusOngoing
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