The impact of genotype on plasma and cerebral spinal fluid pharmacokinetics of celecoxib in children: a randomised controlled single-centre trial

Children's Hospital of Eastern Ontario Research Institute (Canada)0 个研究点目标入组 20 人开始时间: 2009年10月6日最近更新: 2015年1月13日

适应症

试验速览

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•Both males and females, age 2-18 years with haematological malignancy expected to undergo five lumbar punctures.

•1. Serum creatinine >2 X upper normal limit (UNL)
•2. Abnormal liver function; namely alanine aminotransferase (ALT) >1.5 X UNL, alkaline phosphatase (ALP) > 5X UNL, total bilirubin >2 X UNL
•3. History of peptic ulcer disease
•4. Allergy to celecoxib, sulfonamide compounds or non steroidal anti-inflammatory drugs (NSAIDs)
•5. Patients receiving CYP2C9 inhibitors fluconazole, amiodarone and oxandrolone
•6. Patients receiving CYP2C9 inducers rifampin and phenobarbitol
•7. Extremes of body mass index (BMI) (age related below 10th or above 90th percentile)
•8. Parents of any participants, irrespective of age, who are unable to read and understand instructions relayed in English or French
•9. Participant and/or parents of any participants, irrespective of age, who suffer from dementia, psychosis, significant developmental delay or other impairment that would prohibit the understanding and giving of informed consent or assent or the participation in self-care or toxicity reporting

发起方

Children's Hospital of Eastern Ontario Research Institute (Canada)