Pharmacokinetics of oxycodone in preterm and in infants - Oxy-neo-infant

• Conditions: Severe pain states which need oxycodone analgesia.; MedDRA version: 14.1Level: SOCClassification code 10042613Term: Surgical and medical proceduresSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: PTClassification code 10033371Term: PainSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2011-005612-28-FI
• Lead Sponsor: Hannu Kokki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-18
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.