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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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    EudraCT Number:2013-002774-51
    Sponsor's Protocol Code Number:BrePainGenOxyc1
    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:2013-06-28
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2013-002774-51
    A.3Full title of the trial
    Genetic influences on pain and oxycodone consumption following mastectomy
    Rintasyövän vuoksi hoidettavien naisten kivun hoito
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Genetic influence on pain and analgesic (oxycodone) requirement after breast cancer surgery.
    Perimän vaikutus kipuun ja kipulääkkeen (oksikodoni) tarpeeseen rintasyövän vuoksi tehdyn leikkauksen jälkeen.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberBrePainGenOxyc1
    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.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 supportAcademy of Finland
    B.4.1Name of organisation providing supportHelsinki University Central Hospital
    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 pointPain Clinic
    B.5.3 Address:
    B.5.3.1Street AddressHaartmaninkatu 2A
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post code00029 HUS
    B.5.4Telephone number3580947175640
    B.5.5Fax number3580947175641
    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. name Oxanest 10 mg/ml inj
    D. of the Marketing Authorisation holderOy Leiras Takeda Pharmaceuticals
    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.3.4Pharmaceutical 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 124-90-3
    D.3.9.3Other descriptive nameOXYCODONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03583MIG
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Women who are scheduled for breast cancer surgery.
    Rintasyövän vuoksi leikkaukseen tulevat naiset.
    E.1.1.1Medical condition in easily understood language
    Women who will undergo surgery for breast cancer.
    Rintasyövän vuoksi leikkaukseen tulevat naiset.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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
    To assess plasma concentrations of oxycodone and its main metabolites that provide satisfactory pain relief after breast cancer surgery.
    Selvittää plasma oksikodonin ja sen metaboliittien pitoisuudet, joilla saavutetaan riittävä kivun livittyminen
    E.2.2Secondary objectives of the trial
    To assess how much oxycodone is needed during the first 20 postoperative hours for pain relief after breast cancer surgery.
    Selvittää kuinka paljon oksikonia tarvitaan rintasyöpäleikkauksen jälkeen ensimmäisten 20 tunnin aikana.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women, aged 18-75 years, who have breast cancer and who are scheduled to have breast resection or mastectomy with or without axillary clearance and who sign an informed consent form.
    Rintasyöpäleikkaukseen tulevat 18-75-vuotiaat naiset, joille tehdään joko rinnan resektio tai poisto kainaloevakuaation kera tai ilman ja jotka allekirjoittavat tietoon perustuvan suostumuksen.
    E.4Principal exclusion criteria
    Patients who have known metastases (other than axillary lymph nodes), who have clinically relevant kidney or liver failure or who are allergic to oxycodone.
    Potilaat, joilla on metastasoitunut tauti (lukuun ottamatta kainaloimusolmukkkeita), joilla on kliinisesti merkittävä munuaisten tai maksan vajaatoiminta tai jotka ovat yliherkkiä oksikodonille.
    E.5 End points
    E.5.1Primary end point(s)
    Satisfactory pain relief.
    Riittävä kivun livitys.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be administered oxycodone 0.05 mg/kg intravenously if needed every 5 minutes until satisfactory pain relief is achieved. At this point pain intensity is assessed with visual analogue scale (VAS) and blood is drawn for future assessment of plasma oxycodone & metabolite concentrations. Aftr this pain intenisty is assessed every 5 minutes until 15 minutes and thereafter every 15 minutes until th patient requested a further dose of analgesic. At this point pain is measured with VAS and blood is drawn after which oxycodone is adminsitered.
    Potilaille annetaan tarvittaessa laskimoon oksikodonia 0.05 mg/kg 5 minuutin välein kunnes potilas on tyytyväinen kivun lievitykseen. Tällöin mitataan kivun voimakkuus visuaalisella analogiasteikolla (VAS) ja otetaan verinäyte myöhemmin tehtävää plasman oksikodonin ja sen metaboliittien määritystä varten. Tämän jälkeen kivun voimakkuutta kysytään 5 minuutin välein kunnes 15 minuuttiin asti ja sen jälkeen 15 minuutin välein kunnes potilas tarvitsee seuraavan kerran kipulääkettä. Tuolloin mitataan kivun voimakkuus ja otetaan verinäyte, minkä jälkeen annetaan oksikodonia 0.05 mg/kg laskimoon.
    E.5.2Secondary end point(s)
    Total amount of oxycodone consumed in the postanaesthesia care unit and thereafter on the ward via a PCA (patient controlled analgesia) device during 20 hours from surgery.
    Oksikodonin kokonaiskulutus heräämövaiheen aikana sekä osastolla potilaan itseannostelulaitteen (PCA) avulla leikkauksen jälkeisten 20 tunnin aikana.
    E.5.2.1Timepoint(s) of evaluation of this end point
    20 hours after surgery.
    20 tuntia leikkauksen jälkeen
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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. 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
    The study regarding acute postoperative pain ends when the patient is referred home. However, questionnaires are sent at regular intervals afterwards and the patient who develop moderate or severe chronic pain will be treated at the pain clinic.
    Akuutin kivun vaiheen tutkimus päättyy potilaidne kotiutuessa. Heille lähetetään säännöllisin välein kyselylomakkeita ja potilaat, jotka kehittävät kohtalisen tai sitä voimakkaamman kroonisen leikkauksenjälkeisen kivun, hoidetaan kipuklinikalla.
    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 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) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    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 state
    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 Decision2013-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-31
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