Severe pain states which need oxycodone analgesia. MedDRA version: 14.1 Level: SOC Classification code 10042613 Term: Surgical and medical procedures System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10033371 Term: Pain System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Interventions
Trade Name: Oxanest 10mg/ml
Pharmaceutical Form: Injection
INN or Proposed INN: oxycodone hydrochloride trihydrate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentra
Sponsors
Hannu Kokki
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? yes Number of subjects for this age range: 72 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the pharmacokinetics and metabolism of oxycodone in neonates and infants. To develop an optimized oxycodone dosing regimen for neonates and infants.;Secondary Objective: ;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.;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. | — |
Countries
Finland
Outcome results
None listed