E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Severe pain states which need oxycodone analgesia. |
Potilaat, joilla on oksikodonin käyttöä vaativa kiputila. |
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E.1.1.1 | Medical condition in easily understood language |
Severe pain states which need oxycodone analgesia. |
Oksikodonin käyttöä vaativa kiputila. |
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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 | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10042613 |
E.1.2 | Term | Surgical and medical procedures |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
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 |
To describe the pharmacokinetics and metabolism of oxycodone in neonates and infants. To develop an optimized oxycodone dosing regimen for neonates and infants. |
Kuvata oksikodonin metaboliaa ja sen kehittymistä sekä määrittää oksikodonin optimaalista annostelua keskosilla ja imeväisillä. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Age at least 25 weeks (postmenstrual age) and at most 2 years (postnatal age)
- The parents of the patient understand the objectives and procedures of the study for which the patient is being recruited.
- The parents of the patients have provided a written informed consent about the patient's participation in the study
- The patient has a severe pain state which requires oxycodone treatment.
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- Ikä vähintään 25 viikkoa (raskausajan ikä) ja enintään 2 vuotta (syntymänjälkeinen ikä)
- Tutkittavan vanhemmat ymmärtävät suunnitellun tutkimuksen ja siinä tehtävät toimenpiteet
- Tutkittavan vanhemmat ovat antaneet kirjallisen suostumuksen tutkittavan osallistumisesta tutkimukseen
- Oksikodonilääkitystä vaativa kiputila
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E.4 | Principal exclusion criteria |
- The patient is <25 weeks of postmenstrual age
- The patient is >2 years old (postnatal age)
- The patients has been included in a clinical trial other than this one during the past month
- The patient is sensitive to oxycodone or some other ingredient present in the study drug formulation.
- The patient is being treated, or has been treated with CYP3A4 inhibitors (e.g. ketoconazole) or CYP2D6 inhibitors (e.g. paroxetine) during the past month
- The parents of the patient have not given a written informed consent
- Some other reason because of which the patient is not considered suitable for inclusion in the trial. |
- Potilas on alle 25 viikon ikäinen (raskausajan ikä) keskonen
- Potilas on >2 vuotta vanha (syntymänjälkeinen ikä)
- Potilas on tai on ollut mukana muussa lääketutkimuksessa edeltävän kuukauden aikana, lukuun ottamatta tätä nimenomaista tutkimusta
- Yliherkkyys oksikodonille tai valmisteen sisältämille aineosille
- MAO-estäjien käyttö, CYP3A4 inhibiittorien, kuten ketokonatsolin käyttö, CYP2D6 inhibiittorien, kuten paroksetiinin käyttö edeltävän kuukauden aikana
- Tutkittavan vanhemmat eivät ole antaneet kirjallista suostumusta
- Muu syy, jonka takia tutkija arvioi, ettei potilas sovi tutkimukseen
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E.5 End points |
E.5.1 | Primary end point(s) |
Pharmacokinetic parameters, especially clearance. The correlation of these parameters with age and weight. The amount of metabolites in plasma and urine. |
Kullekin potilaalle lasketut farmakokineettiset tunnusluvut (tärkeimpänä puhdistuma) ja näiden tunnuslukujen korrelaatio ikään ja painoon. Lisäksi ensisijaisia tulosmuuttujia ovat oksikodonin metaboliitit veressä ja virtsassa. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After the administration of the study drug, blood samples will be collected from the patient (maximum of 6 samples per patient per study occasion). Urine will be collected up to 48 hours after study drug administration, whenever possible. |
Tutkimuslääkkeen annostelun jälkeen tutkittavilta otetaan verinäytteitä (max 6 kpl per potilas per tutkimuskerta) enintään vuorokauden ajalta. Lisäksi tutkittavilta kerätään virtsaa 48 tunnin ajan, mikäli tämä on mahdollista. |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |