[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100159142":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":45,"centralContacts":49,"locations":55,"responsibleParty":72,"collaborators":44,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":44,"eligibilityCriteria":80,"healthyVolunteers":77,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":44,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":57,"whyStopped":44,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Children's Hospital of Eastern Ontario","OTHER",[8,14,18,24,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase I: Study drug Group 1 (Celecoxib 7 mg\u002Fkg)","ACTIVE_COMPARATOR","Study participants randomized to this group will receive a single 7 mg\u002Fkg dose of celecoxib approximately 121-180 minutes before their scheduled LP ± BMA. The study medication will be a liquid and the study participant will be asked to drink it.",[13],"Drug: Celecoxib",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase I: Study drug Group 2 (Celecoxib 14 mg\u002Fkg)","Study participants randomized to this group will receive a single 14 mg\u002Fkg dose of celecoxib approximately 121-180 minutes before their scheduled LP ± BMA. The study medication will be a liquid and the study participant will be asked to drink it.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Phase II: Group A: Placebo","PLACEBO_COMPARATOR","Study participants will receive a single dose of placebo. Placebo will be liquid. The study participant will drink it.\n\nThe timing of when the study participants in this group will take placebo will be determined in a second randomization:\n\nGroup A.1: will take placebo 15 to 24 hours prior to having their LP±BMA. The study medication will be taken at home.\n\nGroup A.2: will take placebo 5 to 15 hours prior to having their LP±BMA. The study medication will be taken at home.\n\nGroup A.3: will take the placebo 3 to 5 hours prior to having their LP±BMA. The study medication will be taken at home.\n\nGroup A.4: will take the study medication 1 to 2 hours prior to having their LP±BMA. The study medication will be taken at the hospital.\n\nGroup A.5: will take the study medication 0 to 60 minutes prior to having their LP±BMA. The study medication will be taken at the hospital.",[23],"Drug: Placebo",{"label":25,"type":10,"description":26,"interventionNames":27},"Phase II: Group B: Study drug (Celecoxib 7 mg\u002Fkg)","Study participants randomized to this group you will receive a single 7 mg\u002Fkg dose of celecoxib which will be in a liquid form, and the study participant will drink it.\n\nThe timing of when the study participant in this group will take this medication will be determined in a second randomization:\n\nGroup B.1: will take the study medication 15 to 24 hours prior to having their LP±BMA. The study medication will be taken at home.\n\nGroup B.2: will take the study medication 5 to 15 hours prior to having their LP±BMA. The study medication will be taken at home.\n\nGroup B.3: will take the study medication 3 to 5 hours prior to having their LP±BMA. The study medication will be taken at home.\n\nGroup B.4: will take the study medication 1 to 2 hours prior to having their LP±BMA. The study medication will be taken at the hospital.\n\nGroup B.5: will take the study medication 0 to 60 minutes prior to having your LP±BMA. The study medication will be taken at the hospital.",[13],{"label":29,"type":10,"description":30,"interventionNames":31},"Phase II: Group C: Study drug (Celecoxib 14 mg\u002Fkg)","Study participants randomized to this group you will receive a single 14 mg\u002Fkg dose of celecoxib which will be in a liquid form, and the study participant will drink it.\n\nThe timing of when the study participant in this group will take this medication will be determined in a second randomization:\n\nGroup C.1: will take the study medication 15 to 24 hours prior to having their LP±BMA. The study medication will be taken at home.\n\nGroup C.2: will take the study medication 5 to 15 hours prior to having their LP±BMA. The study medication will be taken at home.\n\nGroup C.3: will take the study medication 3 to 5 hours prior to having their LP±BMA. The study medication will be taken at home.\n\nGroup C.4: will take the study medication 1 to 2 hours prior to having your LP±BMA. The study medication will be taken at the hospital.\n\nGroup C.5: will take the study medication 0 to 60 minutes prior to having your LP±BMA. The study medication will be taken at the hospital.",[13],[33,40],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Celecoxib","In Phase I twenty (20) children will receive either celecoxib 14 or 7 mg\u002Fkg 120-180 minutes prior to lumbar puncture (LP). In Phase II forty-five (45) children will receive celecoxib 14 mg\u002Fkg, 7 mg\u002Fkg or placebo in one of 5 time intervals, 1-24 hours prior to LP.",[9,15,25,29],[39],"Celebrex",{"type":34,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Placebo","In Phase II forty-five (45) children will receive celecoxib 14 mg\u002Fkg, 7 mg\u002Fkg or placebo in one of 5 time intervals, 1-24 hours prior to LP.",[19],null,[46],{"name":47,"affiliation":5,"role":48},"Dr Kimmo Murto, MD","PRINCIPAL_INVESTIGATOR",[50],{"name":47,"role":51,"phone":52,"phoneExt":53,"email":54},"CONTACT","613-737-7600","3065","kmurto@cheo.on.ca",[56],{"facility":5,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Ottawa","Ontario","K1H 8L1","Canada","CA",{"type":64,"coordinates":65},"Point",[66,67],-75.69812,45.41117,{"lat":67,"lon":66},[70,71],{"name":47,"role":51,"phone":52,"phoneExt":53,"email":54},{"name":47,"role":48,"phone":44,"phoneExt":44,"email":44},{"type":48,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Kimmo Murto","Director of Research, Department of Anesthesiology & Pain Medicine","100159142","phase-2-celecoxib-plasma-and-cerebral-spinal-fluid-pharmacokinetics-in-children-100159142",false,"NCT01344200","CELECOXIB Plasma and Cerebral Spinal Fluid Pharmacokinetics in Children","Inclusion Criteria:\n\nChildren 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 patients would have achieved remission an average of 6 months earlier.\n\nExclusion Criteria:\n\n1. Age \\\u003C 2yrs and \\>12yrs old\n2. Children with non-hematologic malignancies\n3. AML\n4. Children undergoing a bone marrow aspiration (BMA) only\n5. Serum creatinine \\> 2 X UNL (upper normal limit) within 30 days\n6. Abnormal liver function; alanine aminotransferase (ALT) \\> 2 X UNL, Aspartate aminotransferase (AST) \\> 2 X UNL, total \\& direct bilirubin \\> 2 X UNL within 30 days\n7. History of peptic ulcer disease\n8. Allergy to celecoxib or NSAIDs (note: sulpha allergy does not exclude celecoxib)\n9. Recent (within 7 days) celecoxib ingestion\n10. Patients receiving CYP2C9 inhibitors fluconazole, amiodarone, oxandrolone\n11. Patients receiving CYP2C9 inducers rifampin and phenobarbitol\n12. Patients receiving high (≥ 5 gm\u002Fm2) and\u002F or escalating doses of methotrexate.\n13. Extremes of body mass index (BMI) (BMI \\\u003C5th percentile or \\>95th percentile)\n14. Parents of any participants, irrespective of age, who are unable to read and understand instructions relayed in English or French\n15. Participant and\u002For 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\n16. Patient enrolled in another trial\n17. Pregnancy.","ALL","2 Years","12 Years",{"count":85,"type":86},65,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","Celecoxib is effective for reducing postoperative pain in adults. Children use celecoxib more rapidly than adults and require higher doses. Celecoxib is partially metabolized in the liver by a certain enzyme. A person's genetic variation of this enzyme can influence how well their body uses Celecoxib. Furthermore, Celecoxib down-regulates P-glycoprotein (P-gp), a drug efflux transporter located at the blood brain barrier responsible for central nervous system (CNS) extrusion of ondansetron and possibly fentanyl; therefore celecoxib may augment the CNS effects of these drugs.\n\nUnderstanding the blood and cerebrospinal fluid (CSF) profile of celecoxib in children and the influence of genetics on metabolism would help to develop appropriate celecoxib dosing in children for various treatment options.",[92],"Pharmacokinetics of Celecoxib in Children",[94,35,95,96,97,98,99,100],"Pharmacokinetics","Children","Pharmacogenetic","ABCB1 genotype","CYP2C9 genotype","CSF","Plasma","2024-02-07",{"date":103,"type":104},"2024-02-08","ACTUAL",{"date":106,"type":104},"2024-01-29",{"date":108,"type":86},"2027-02-01",{"name":5,"class":6},1]