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    Summary
    EudraCT Number:2015-005561-23
    Sponsor's Protocol Code Number:KodAmpPain_1.0
    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:2016-01-14
    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 number2015-005561-23
    A.3Full title of the trial
    Effect of CYP2D6 polymorphism on the analgesic efficacy and side-effects of codeine
    CYP2D6-isoentsyymin geneettisen polymorfian vaikutus kodeiinin analgeettiseen tehoon ja haittavaikutuksiin päiväkirurgisilla potilailla
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of hereditary factors on the analgesic efficacy and side-effects of codeine
    Perimän vaikutus kodeiinin tehoon ja haittavaikutuksiin
    A.4.1Sponsor's protocol code numberKodAmpPain_1.0
    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 SponsorKlaus Olkkola
    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 organisationKlaus Olkkola
    B.5.2Functional name of contact pointKlaus Olkkola
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 340 (Haartmaninkatu 4)
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post codeFI-00029 HUS
    B.5.3.4CountryFinland
    B.5.4Telephone number358407583655
    B.5.6E-mailklaus.olkkola@helsinki.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 Panacod
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi 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 namePanacod
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namePARACETAMOL
    D.3.9.4EV Substance CodeSUB09611MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameCODEINE PHOSPHATE HEMIHYDRATE
    D.3.9.4EV Substance CodeSUB13428MIG
    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
    Postoperative pain
    Leikkauksenjälkeinen kipu
    E.1.1.1Medical condition in easily understood language
    Postoperative pain
    Leikkauksenjälkeinen kipu
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10036236
    E.1.2Term Postoperative pain relief
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10036276
    E.1.2Term Postoperative analgesia
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    What is the relationship between CYP2D6 genotype and the analgesic efficacy and side-effects of codeine in patients undergoing ambulatory surgery
    Millainen yhteys CYP2D6-genotyypillä ja kodeiinin analgeettisella teholla ja haittavaikutuksilla on päiväkirurgisilla potilailla
    E.2.2Secondary objectives of the trial
    With the use of genome wide association methods it will be studied whether heridatary factors will predict the pharmacokinetics and pharmacodynamics of codeine and paracetamol
    Perimänlaajuisia menetelmiä käyttäen tutkitaan voidaanko perintötekijöillä, niiden ilmentymisellä veressä tai metabolomimäärityksillä (plasman aineenvaihduntatuotteiden laaja kartoitus) ennakoida kodeiinin ja parasetamolin pitoisuuksia ja niiden toivottuja ja ei-toivottuja vaikutuksia tai niiden välisiä yhteisvaikutuksia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients undergoing ambulatory surgery at the Jorvi Hospital. Panacod used for postoperative pain.
    Tutkimus tehdään Jorvin sairaalan päiväkirurgisessa yksikössä. Tutkimusryhmään pyydetään 1000 sellaista päiväkirurgiseen leikkaukseen tulevaa potilaista, joiden kivun hoidoksi suunnitellaan käytettävän parasetamolin ja kodeiinin yhdistelmävalmistetta, jossa on yhdessä kapselissa 30 mg kodeiinifosfaattihemihydraattia ja 500 mg parasetamolia (mm. valmisteet Panacod®, Codaxol®).
    E.4Principal exclusion criteria
    Age < 18 yrs or > 70 yrs, ASA > 3, weight < 50 kg, BMI ≥ 40 kg/m2, pregnancy, lactation, allergy to any of the drugs used in the study, previous side-effects with the study drugs, previous addiction problems with chemical substances, ongoing opioid treatmeat, inability to use NRS-scale.
    Tutkimuksen poissulkukriteereinä ovat: ikä < 18 v, ikä > 70 v, ASA - luokka > 3, paino < 50 kg, BMI ≥ 40 kg/m2, raskaus, imetys, yliherkkyys jollekin tutkimuksessa käytetyistä lääkeaineista, tutkimuksessa käytettävien lääkkeiden yhteydessä aiemmin ilmenneet merkittävät haittavaikutukset, aikaisempi päihdeongelma, käytössä oleva opioidilääkitys, sekä kykenemättömyys käyttää NRS-asteikkoa.
    E.5 End points
    E.5.1Primary end point(s)
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 No
    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.8.3 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months10
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 2016-01-14. 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 state1000
    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 suunniteltu
    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 Decision2016-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-16
    P. End of Trial
    P.End of Trial StatusOngoing
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