How genetics may impact the metabolism and elimination of celecoxib from the body and brain of childre
- Conditions
- Haematological malignancyCancerOther and unspecified malignant neoplasms of lymphoid, haematopoietic and related tissue
- Registration Number
- ISRCTN07429476
- Lead Sponsor
- Children's Hospital of Eastern Ontario Research Institute (Canada)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method