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New treatment option for Pharmacokinetics of Celecoxib in Children
Official title CELECOXIB Plasma and Cerebral Spinal Fluid Pharmacokinetics in Children
ClinicalTrials.gov ID: NCT01344200
What this study is testing
What is Celecoxib?
Celecoxib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pharmacokinetics of celecoxib in children.
Also referred to as Celebrex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Celecoxib is effective for reducing postoperative pain in adults. Children use celecoxib more rapidly than adults and require higher doses.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 12
You may be able to join if
- Children aged 2-12 years, undergoing Maintenance phase chemotherapy for hematological malignancies and lymphomas (i.e. acute lymphoblastic leukemia...
You likely can't join if
- Age \ 12yrs old
- Children with non-hematologic malignancies
- Children undergoing a bone marrow aspiration (BMA) only
- Serum creatinine \> 2 X UNL (upper normal limit) within 30 days
- Abnormal liver function; alanine aminotransferase (ALT) \> 2 X UNL, Aspartate aminotransferase (AST) \> 2 X UNL, total \& direct bilirubin \> 2 X UNL...
- History of peptic ulcer disease
See the full eligibility criteria
- Children aged 2-12 years, undergoing Maintenance phase chemotherapy for hematological malignancies and lymphomas (i.e. acute lymphoblastic leukemia [ALL] and lymphoblastic lymphomas [LLy] at CHEO. At this point, all...
- Age \ 12yrs old
- Children with non-hematologic malignancies
- Children undergoing a bone marrow aspiration (BMA) only
- Serum creatinine \> 2 X UNL (upper normal limit) within 30 days
- Abnormal liver function; alanine aminotransferase (ALT) \> 2 X UNL, Aspartate aminotransferase (AST) \> 2 X UNL, total \& direct bilirubin \> 2 X UNL within 30 days
- History of peptic ulcer disease
- Allergy to celecoxib or NSAIDs (note: sulpha allergy does not exclude celecoxib)
- Recent (within 7 days) celecoxib ingestion
- Patients receiving CYP2C9 inhibitors fluconazole, amiodarone, oxandrolone
- Patients receiving CYP2C9 inducers rifampin and phenobarbitol
- Patients receiving high (≥ 5 gm/m2) and/ or escalating doses of methotrexate.
- Extremes of body mass index (BMI) (BMI \ 95th percentile)
- Parents of any participants, irrespective of age, who are unable to read and understand instructions relayed in English or French
- Participant and/or parents of any participants, irrespective of age, who suffer from dementia, psychosis or any impairment that would prohibit the understanding and giving of informed consent or study-related reporting
- Patient enrolled in another trial
- Pregnancy.
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.