E.1 Medical condition or disease under investigation |
E.1.1 | Medical 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 . |
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E.1.1.1 | Medical 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 . |
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E.1.1.2 | Therapeutic 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.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033371 |
E.1.2 | Term | Pain |
E.1.2 | System Organ Class | 10018065 - General disorders and administration site conditions |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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.
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Cilj raziskave je z dvojno slepim poskusom primerjati uspešnost pooperativne analgezije dveh različno močnih odmerkov kombinacije zdravila tramadol in paracetamola na jakost akutne bolečine. |
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E.2.2 | Secondary 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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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). |
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E.5 End points |
E.5.1 | Primary 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
after 28 days of treatment |
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E.5.2 | Secondary 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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
after 28 days of treatment and after 1 year after inclusion into the trial. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Use of placebo only in purpose of comparing the lower and higher dosage of Doreta drug. |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |