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Nonsteroidal Anti-inflammatory Drug

Celecoxib for Pharmacokinetics of Celecoxib

Phase 2
Recruiting
Led By Dr Kimmo Murto, MD
Research Sponsored by Children's Hospital of Eastern Ontario
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 patients would have achieved remission an average of 6 months earlier.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0, the day of the procedure, after taking study medication.
Awards & highlights

Study Summary

This trial found that celecoxib is effective in reducing postoperative pain in adults, while children use celecoxib more rapidly and require higher doses.

Who is the study for?
This trial is for children aged 2-12 undergoing chemotherapy for certain blood cancers and in remission. They must not have kidney or liver issues, recent celecoxib use, be on conflicting medications, have a history of ulcers, extreme BMI, or other trials ongoing. Pregnant individuals or those with allergies to NSAIDs are excluded.Check my eligibility
What is being tested?
The study tests how Celecoxib behaves in the blood and cerebrospinal fluid of children and examines genetic factors affecting its metabolism. It compares Celecoxib's effects against a placebo to understand dosing for pain management post-surgery.See study design
What are the potential side effects?
Celecoxib may cause stomach problems like ulcers, increase risk of heart attack or stroke in adults (risk in children is unclear), allergic reactions, liver/kidney issues, and could potentially interact with other CNS drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is 2-12 years old, in remission from leukemia or lymphoma, and receiving maintenance chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0, the day of the procedure, after taking study medication.
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, the day of the procedure, after taking study medication. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Develop a PK model that explores the relationship between plasma and CSF celecoxib concentrations and the impact of covariates including age, weight and genetics using nonlinear mixed effects models.
Mean celecoxib CSF concentration (ug/L) at the following time intervals (mins): 0-60, 61-120,121-180,181-300, 301-900 and 901-1440.
Celecoxib
+1 more
Secondary outcome measures
Correlation between CSF and plasma study drug concentrations
Correlation with qualitative P-gp expression
Determine Area under the plasma concentration versus time curve (AUC)
+10 more

Trial Design

5Treatment groups
Active Control
Placebo Group
Group I: Phase II: Group B: Study drug (Celecoxib 7 mg/kg)Active Control1 Intervention
Study participants randomized to this group you will receive a single 7 mg/kg dose of celecoxib which will be in a liquid form, and the study participant will drink it. The timing of when the study participant in this group will take this medication will be determined in a second randomization: Group 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. Group 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. Group 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. Group 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. Group 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.
Group II: Phase II: Group C: Study drug (Celecoxib 14 mg/kg)Active Control1 Intervention
Study participants randomized to this group you will receive a single 14 mg/kg dose of celecoxib which will be in a liquid form, and the study participant will drink it. The timing of when the study participant in this group will take this medication will be determined in a second randomization: Group 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. Group 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. Group 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. Group 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. Group 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.
Group III: Phase I: Study drug Group 1 (Celecoxib 7 mg/kg)Active Control1 Intervention
Study participants randomized to this group will receive a single 7 mg/kg 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.
Group IV: Phase I: Study drug Group 2 (Celecoxib 14 mg/kg)Active Control1 Intervention
Study participants randomized to this group will receive a single 14 mg/kg 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.
Group V: Phase II: Group A: PlaceboPlacebo Group1 Intervention
Study participants will receive a single dose of placebo. Placebo will be liquid. The study participant will drink it. The timing of when the study participants in this group will take placebo will be determined in a second randomization: Group A.1: will take placebo 15 to 24 hours prior to having their LP±BMA. The study medication will be taken at home. Group A.2: will take placebo 5 to 15 hours prior to having their LP±BMA. The study medication will be taken at home. Group A.3: will take the placebo 3 to 5 hours prior to having their LP±BMA. The study medication will be taken at home. Group 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. Group 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.

Find a Location

Who is running the clinical trial?

Children's Hospital of Eastern OntarioLead Sponsor
125 Previous Clinical Trials
55,397 Total Patients Enrolled
Dr Kimmo Murto, MDPrincipal InvestigatorChildren's Hospital of Eastern Ontario

Media Library

Celecoxib (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT01344200 — Phase 2
Pharmacokinetics of Celecoxib Research Study Groups: Phase II: Group B: Study drug (Celecoxib 7 mg/kg), Phase II: Group C: Study drug (Celecoxib 14 mg/kg), Phase I: Study drug Group 1 (Celecoxib 7 mg/kg), Phase II: Group A: Placebo, Phase I: Study drug Group 2 (Celecoxib 14 mg/kg)
Pharmacokinetics of Celecoxib Clinical Trial 2023: Celecoxib Highlights & Side Effects. Trial Name: NCT01344200 — Phase 2
Celecoxib (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01344200 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper bound of participants in this experiment?

"This trial is no longer accepting new participants. The original posting date was December 1st, 2022 and the last update occurred on August 19th, 2022. However, there are currently one study involving celecoxib which has yet to reach its recruitment goal and 40 Phase II studies for Study Drug (Celecoxib 7 mg/kg) still in search of volunteers."

Answered by AI

Does this study allow seniors as participants?

"This trial is recruiting participants between the ages of 2 and 12. There are 9 studies for minors and 31 studies available to those over 65 years old."

Answered by AI

What are the principal objectives of this research endeavor?

"The primary aim of this clinical trial seeks to evaluate the cerebrospinal fluid (CSF) levels of celecoxib administered in 120-180 minutes following ingestion. Secondary goals include determining plasma peak concentration, pharmacogenetic data from CYP2C9 genotypes, and a graph plotting pain scores against total plasma concentrations."

Answered by AI

What clinical applications do researchers most commonly utilize Celecoxib 7 mg/kg for during Phase II: Group B?

"Group B of Phase II of this study drug (Celecoxib 7 mg/kg) is designed to remedy pain, primary dysmenorrhoea, and rheumatoid arthritis."

Answered by AI

What risks are associated with utilizing Celecoxib 7 mg/kg in Phase II: Group B?

"Our Power team gave Phase II: Group B: Study drug (Celecoxib 7 mg/kg) a safety score of 2, as this is still only in the second phase and while there are indications that it may be safe, efficacy has not yet been established."

Answered by AI

Are there any vacancies for participants in this investigation?

"This trial is no longer enrolling participants. Initially posted on December 1st 2022, the study was last edited on August 19th 2022. If other studies are being explored, there is one clinical trial for celecoxib and forty Phase II: Group B trials that require additional volunteers."

Answered by AI

Who meets the eligibility criteria for this trial?

"This trial is recruiting 65 minors between the ages of 2 and 12 that have been prescribed celecoxib. Specifically, these young candidates should be undergoing chemotherapy for a hematological cancer or lymphoma at CHEO; also, all participants must have achieved remission approximately 6 months prior to commencement."

Answered by AI
~43 spots leftby Jan 2026