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

Hannu Kokki0 个研究点开始时间: 2012年1月18日最近更新: 2012年3月20日

适应症

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•-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

•- 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.

发起方

Hannu Kokki