Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36092   clinical trials with a EudraCT protocol, of which   5933   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-000992-28
    Sponsor's Protocol Code Number:KCT04/2015-DORETAonko/SI
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-06-10
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2015-000992-28
    A.3Full title of the trial
    A comparison of the severity of acute pain and the frequency of chronic pain after post-operative analgesia of lower and higher intensity following surgical emptying of the axillary gland in breast cancer patients in relation to the pharmacogenomics in the metabolism of tramadol – a prospective, double blind, randomised clinical trial
    Primerjava jakosti akutne in pogostosti kronične bolečine po šibkejši in močnejši pooperativni analgeziji po operaciji izpraznitve pazdušnih bezgavk zaradi raka dojke glede na farmakogenomiko presnove tramadola – prospektivna dvojno slepa randomizirana raziskava
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A comparison of the severity of acute pain and the frequency of chronic pain after post-operative analgesia of lower and higher intensity following surgical emptying of the axillary gland in breast cancer patients in relation to the pharmacogenomics in the metabolism of tramadol – a prospective, double blind, randomised clinical trial
    Primerjava jakosti akutne in pogostosti kronične bolečine po šibkejši in močnejši pooperativni analgeziji po operaciji izpraznitve pazdušnih bezgavk zaradi raka dojke glede na farmakogenomiko presnove tramadola – prospektivna dvojno slepa randomizirana raziskava
    A.4.1Sponsor's protocol code numberKCT04/2015-DORETAonko/SI
    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 SponsorKrka, d.d., Novo mesto
    B.1.3.4CountrySlovenia
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKrka, d.d., Novo mesto
    B.4.2CountrySlovenia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKrka, d.d., Novo mesto
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressDunajska cesta 65
    B.5.3.2Town/ cityLjubljana
    B.5.3.3Post code1000
    B.5.3.4CountrySlovenia
    B.5.4Telephone number0038641589769
    B.5.6E-mailtanja.kohek@krka.biz
    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 Doreta
    D.2.1.1.2Name of the Marketing Authorisation holderKRKA, tovarna zdravil, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija
    D.2.1.2Country which granted the Marketing AuthorisationSlovenia
    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 nameDoreta
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNtramadol
    D.3.9.3Other descriptive nameTRAMADOL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04927MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number37.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNparacetamol
    D.3.9.3Other descriptive namePARACETAMOL
    D.3.9.4EV Substance CodeSUB09611MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number325
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute pain after surgical emptying of the axillary gland in breast cancer patients.
    Bolečina po operaciji raka dojke z izpraznitvijo pazdušnih bezgavk .
    E.1.1.1Medical condition in easily understood language
    Acute pain after surgical emptying of the axillary gland in breast cancer patients.
    Bolečina po operaciji raka dojke z izpraznitvijo pazdušnih bezgavk .
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10033371
    E.1.2Term Pain
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the trial is the effectiveness of postoperative analgesia of two different doses (with double-blind procedure) of potent combination of tramadol and paracetamol in acute pain intensity.
    Cilj raziskave je z dvojno slepim poskusom primerjati uspešnost pooperativne analgezije dveh različno močnih odmerkov kombinacije zdravila tramadol in paracetamola na jakost akutne bolečine.
    E.2.2Secondary objectives of the trial
    - to determine if the expression of genes for the metabolism of tramadol affect on the effectiveness of the treatment of acute pain and on frequency of adverse reactions during the trial
    - to compare the performance of postoperative analgesia of two different doses of potent combination of tramadol and paracetamol to prevent the development of chronic pain.
    - ugotoviti, če izraženost genov za presnovo tramadola vpliva na učinkovitost zdravljenja akutne bolečine in pogostost neželenih učinkov
    - primerjati uspešnost pooperativne analgezije dveh različno močnih odmerkov kombinacije zdravila tramadol in paracetamola za preprečevanje razvoja kronične bolečine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Surgical emptying of the axillary gland in breast cancer patients.
    - Age of the patients between 18 and 70 years.
    - Signed on the voluntary consent of the patient.
    - Odstranitev pazdušnih bezgavk zaradi raka dojke.
    - Starost bolnic med 18 in 70 let.
    - Podpisana prostovoljna privolitev bolnice.
    E.4Principal exclusion criteria
    - the simultaneous reconstruction of the breast tissue extender or free lobe;
    - hypersensitivity to the drug used in the study (a local anesthetic, piritramide, tramadol, naproxen, acetaminophen, pantoprazole);
    - the male gender;
    - pregnancy;
    - a high risk because of anesthesia (ASA above 3);
    - under the age of 18 years and above 70;
    - liver and kidney disease;
    - participants taking drugs that may have affect on the outcome of treatment (other analgesics, drugs for the treatment of central nervous system);
    - the presence of a psychiatric disease (dementia, schizophrenia, manic-depressive illness).
    - sočasna rekonstrukcija dojke s tkivnim razširjevalcem ali prostim režnjem;
    - preobčutljivost na zdravila uporabljena v raziskavi (lokalni anestetik, piritramid, tramadol, naproksen, paracetamol, pantoprazol);
    - moški spol;
    - nosečnost;
    - velika ogroženost zaradi anestezije (ASA nad 3);
    - starost pod 18 let in nad 70 let;
    o bolezni jeter in ledvic;
    o bolnice, ki jemljejo zdravila, ki bi lahko vplivala za izid zdravljenja (ostali analgetiki, zdravila za zdravljenje centralnega živčnega sistema);
    o prisotnost psihiatrične bolezni (demenca, shizofrenija, manično depresivna bolezen).
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point of the trial is to determine the effectiveness of postoperative analgesia of two different doses (with double-blind procedure) of potent combination of tramadol and paracetamol in acute pain intensity.
    Primarni cilj raziskave je z dvojno slepim poskusom primerjati uspešnost pooperativne analgezije dveh različno močnih odmerkov kombinacije zdravila tramadol in paracetamola na jakost akutne bolečine.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 28 days of treatment
    E.5.2Secondary end point(s)
    The secondary end points of the trial are:
    - to determine if the expression of genes for the metabolism of tramadol have affect on the effectiveness of the treatment of acute pain and on frequency of side effects during the tria;l
    - to compare the performance of postoperative analgesia of two different doses of potent combination of tramadol and paracetamol to prevent the development of chronic pain.
    • ugotoviti, če izraženost genov za presnovo tramadola vpliva na učinkovitost zdravljenja akutne bolečine in pogostost stranskih sopojavov zdravljenja
    • primerjati uspešnost pooperativne analgezije dveh različno močnih odmerkov kombinacije zdravila tramadol in paracetamola za preprečevanje razvoja kronične bolečine.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 28 days of treatment and after 1 year after inclusion into the trial.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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.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 Yes
    E.8.2.3.1Comparator description
    Use of placebo only in purpose of comparing the lower and higher dosage of Doreta drug.
    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
    LVLS
    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) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state120
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-20
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA