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    Summary
    EudraCT Number:2013-003807-20
    Sponsor's Protocol Code Number:FinAPain-1
    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:2014-02-04
    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 number2013-003807-20
    A.3Full title of the trial
    Periferal local anesthetic infusion for postoperative pain after above knee amputation
    Perifeerinen puuduteinfuusio reisiamputaation jälkeisen kivun hoidossa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Continuous administration of local anesthetic for pain after amputation above knee
    Jatkuva puuduteannostelu reisiamputaation jälkeisen kivun hoidossa
    A.4.1Sponsor's protocol code numberFinAPain-1
    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 SponsorHUS, Leikkaus- ja anestesiaosasto
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Naropin
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca Oy Itsehallintokuja 4 02600 Espoo
    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 nameNaropin
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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 number7,5
    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 placeboInfiltration
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pain after amputation above knee
    Leikkauksen jälkeinen kipu reisiamputaation jälkeen
    E.1.1.1Medical condition in easily understood language
    Pain
    Kipu
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10054711
    E.1.2Term Postoperative pain
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Does periferal ropivacaine infusion reduce pain after above knee amputation in patients with atheros sclerosis obliterans
    Vähentääkö perifeerinen ropivakaiini-infuusio kipua reisiamputaation jälkeen ASO tautia sairastavilla potilailla
    E.2.2Secondary objectives of the trial
    Does periferal ropivacaine infusion reduce opioid consumption and opioid reverse affects and prolonged postoperative pain after above knee amputation in patients with atheros sclerosis obliterans
    Vähentääkö perifeerinen ropivakaiini-infuusio opioidien tarvetta ja opioidien aiheuttamia haittavaikutuksia ja pitkittynyttä leikkauksen jälkeistä kipua reisiamputaation jälkeen ASO tautia sairastavilla potilailla
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients presenting for above knee amputation for artheroschlerosis willing to participate, able to give informed consent, able to asses pain using verbal rating scale and assessed to be medically stable so that life expectancy exceeds two weeks as assessed by recruiting anesthesiologist.
    Tutkimukseen rekrytoidaan valtimokovettumataudin aiheuttaman iskemian takia reisiamputaatioon tulevia potilaita, jotka kykenevät antamaan tietoon perustuvan suostumuksen ja ovat halukkaita osallistumaan tutkimukseen, kykenevät arvioimaan kipuaan viisiportaisella sanallisella asteikolla (VRS), ja ovat yleistilaltaan vakaita niin että hoitavan anestesiologin kliinisen arvion mukaan todennäköisesti odotettavissa oleva elinikä on ainakin 2 viikkoa.
    E.4Principal exclusion criteria
    Allergy to amide local anesthetics, operating surgeon unable to insert the catheter as defined in the protocol, planned epidural postoperative pain management.
    Ekskluusiokriteereinä ovat allergia amidipuudutteille, päivystävän kirurgin riittämätön taito asettaa puudutuskatetri tutkimuksessa sovitulla tavalla tai potilaalle suunniteltu epiduraalinen kivun hoito amputaatioleikkauksen jälkeen.
    E.5 End points
    E.5.1Primary end point(s)
    Pain on VRS 0-4.
    Tutkimuksen päälopputulosmuuttuja on leikatun alaraajan amputaatiotyngän kipu levossa mitattuna. Kipua mitataan VRS-asteikolla
    E.5.1.1Timepoint(s) of evaluation of this end point
    Days 1-5 after operation.
    1-5 postoperatiivisena päivänä.
    E.5.2Secondary end point(s)
    Pain on the amputated limb (stump) 1, 3 and 12 months after operation and amputation phantom limb pain 1-5 days after operation and 1,3 and 12 months after operation on VRS scale 0-4, the consumption of opioid 1-5 days after operation and adverse events ( wound infections, re-operations, and other significant adverse events).
    Tutkimuksessa seurataan toissijaisina lopputulosmuuttujina tyngän kipua 1, 3 ja 12 kk leikkauksen jälkeen ja aaveraajan kipua 1-5 vrk ja 1, 3 ja 12 kk leikkauksen jälkeen samalla asteikolla, opioidikipulääkkeiden tarvetta 1-5 päivää leikkauksen jälkeen ja haittavaikutuksia (haavainfektiot, uusintaleikkaukset, muut merkittävät haittatapahtumat).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pain on the amputated limb (stump) 1, 3 and 12 months after operation and amputation phantom limb pain 1-5 days after operation and 1,3 and 12 months after operation on VRS scale 0-4, the consumption of opioid 1-5 days after operation and adverse events ( wound infections, re-operations, and other significant adverse events).
    Tutkimuksessa seurataan toissijaisina lopputulosmuuttujina tyngän kipua 1, 3 ja 12 kk leikkauksen jälkeen ja aaveraajan kipua 1-5 vrk ja 1, 3 ja 12 kk leikkauksen jälkeen samalla asteikolla, opioidikipulääkkeiden tarvetta 1-5 päivää leikkauksen jälkeen ja haittavaikutuksia (haavainfektiot, uusintaleikkaukset, muut merkittävät haittatapahtumat).
    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 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) 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 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 concerned7
    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 contact of the lastsubject (last phone call 12 months after surgery).
    Viimeisen potilaan viimeinen kontakti (soitto) 12 kuukautt leikkauksen jälkeen.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 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 state180
    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
    Ei poikkea normaalista.
    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 Decision2014-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-11
    P. End of Trial
    P.End of Trial StatusOngoing
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