Ondansetron Premedication for Juvenile Idiopathic Arthritis
(OPT-JIA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if taking Ondansetron (Zofran) before methotrexate can reduce nausea and vomiting in children with Juvenile Idiopathic Arthritis (JIA). Methotrexate controls symptoms like joint swelling, but its side effects can be challenging, leading to more costly treatments. By adding Ondansetron, researchers hope more children can continue methotrexate and enhance their quality of life. This trial targets children aged 4 to 16 who are newly starting methotrexate for JIA. As an unphased trial, it offers participants a unique opportunity to potentially improve their treatment experience and contribute to valuable research.
Do I have to stop taking my current medications for the trial?
You may need to stop taking certain medications if they interact with ondansetron, like those affecting serotonin levels or causing heart rhythm issues. The trial does not specify stopping all current medications, but you should discuss your specific situation with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ondansetron is generally well-tolerated and often used to prevent nausea and vomiting. Some studies found that taking ondansetron for several days can slow colon function, but it does not alter certain hormone levels in the blood.
Regarding side effects, ondansetron does not significantly affect hormone balance, which is reassuring. This medication has FDA approval for other uses, indicating its safety. Overall, ondansetron is generally considered safe for children, especially for managing nausea caused by medications like methotrexate.12345Why are researchers excited about this trial?
Researchers are excited about using ondansetron as a premedication for juvenile idiopathic arthritis because it addresses a common side effect of methotrexate treatment: nausea and vomiting. Unlike the standard approach, where ondansetron is given only if nausea occurs, this method proactively prevents discomfort by administering ondansetron before methotrexate. This strategy could improve patient comfort and adherence to treatment, making it a promising option for enhancing the quality of life for young patients.
What evidence suggests that Ondansetron premedication could be effective for reducing nausea in Juvenile Idiopathic Arthritis?
Research shows that ondansetron, a medicine that prevents nausea, can reduce nausea and vomiting in children taking methotrexate for juvenile idiopathic arthritis (JIA). In this trial, some participants will receive ondansetron as premedication before their methotrexate doses, while others will receive it only as needed if they experience nausea or vomiting. Early results suggest that children who take ondansetron before their methotrexate have fewer stomach issues. This may allow them to continue using methotrexate longer without needing more costly treatments. Ondansetron blocks signals in the brain that cause nausea, making it easier for kids to take their medicine. Overall, it seems promising for improving the quality of life for children with JIA.13567
Who Is on the Research Team?
Jaime Guzman, MD, FRCPC
Principal Investigator
University of British Columbia
Are You a Good Fit for This Trial?
This trial is for kids aged 4-16 with Juvenile Idiopathic Arthritis (JIA) in Canada, who are starting methotrexate treatment. They must not be pregnant or planning pregnancy and agree to use contraception if applicable. Kids with certain heart conditions, on specific medications like SSRIs or MAOIs, or allergic to Ondansetron can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive methotrexate with ondansetron premedication or ondansetron as needed for one year
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Folic/folinic acid
- Methotrexate
- Ondansetron
Trial Overview
The study tests whether taking Ondansetron before methotrexate reduces nausea and vomiting in children with JIA. It's a randomized controlled trial comparing the effects of premedication against usual care without it, aiming to improve life quality and medication cost-effectiveness.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Methotrexate and folic/folinic acid as prescribed by physician. Ondansetron: 2 mg if \<15Kg, 4 mg if 15-30Kg, 8 mg if \>30Kg to be taken by mouth one hour before each weekly methotrexate dose, followed by two additional doses every 6-8 hours if awake. To be started from the very first dose of methotrexate.
Methotrexate and folic/folinic acid as prescribed by physician. ONLY children who report nausea/vomiting during regular care will be prescribed ondansetron at the same dose as in experimental group (2 mg if \<15Kg, 4 mg if 15-30Kg, 8 mg if \>30Kg to be taken by mouth one hour before each weekly methotrexate dose, followed by two additional doses every 6-8 hours if awake), as per the attending rheumatologist's discretion
Methotrexate is already approved in United States, Canada, European Union for the following indications:
- Acute lymphoblastic leukemia
- Non-Hodgkin's lymphoma
- Osteosarcoma
- Breast cancer
- Lung cancer
- Head and neck cancer
- Psoriasis
- Rheumatoid arthritis
- Acute lymphoblastic leukemia
- Non-Hodgkin's lymphoma
- Osteosarcoma
- Breast cancer
- Lung cancer
- Head and neck cancer
- Psoriasis
- Rheumatoid arthritis
- Acute lymphoblastic leukemia
- Non-Hodgkin's lymphoma
- Osteosarcoma
- Breast cancer
- Lung cancer
- Head and neck cancer
- Psoriasis
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor
McMaster University
Collaborator
Royal University Hospital Foundation
Collaborator
Université de Montréal
Collaborator
University of Calgary
Collaborator
IWK Health Centre
Collaborator
Memorial University of Newfoundland
Collaborator
McMaster Children's Hospital
Collaborator
London Health Sciences Centre
Collaborator
Alberta Children's Hospital
Collaborator
Citations
Spectrum of Clinical Research in Juvenile Idiopathic Arthritis
A total of 9/72 studies (12.5%) were related to medications other than DMARD and all of them of the interventional type, concerning the ...
The Ondansetron Premedication Trial in Juvenile ...
To evaluate if routine pre-medication with the anti-emetic ondansetron reduces methotrexate intolerance and increases the proportion of children with JIA able ...
3.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT04169828/the-ondansetron-premedication-trial-in-juvenile-idiopathic-arthritisThe Ondansetron Premedication Trial in Juvenile ...
This registry-based pragmatic randomized controlled trial will evaluate if routine premedication with the anti-emetic drug Ondansetron, reduces ...
Preliminary Results of the Ondansetron Pre-medication ...
Our aim was to evaluate if routine premedication with the anti-emetic ondansetron reduces MTX intolerance and increases the proportion of children able to ...
Preliminary Results of the Ondansetron Pre-medication Trial ...
Preliminary Results of the Ondansetron Pre-medication Trial in Juvenile Idiopathic Arthritis: A Pragmatic Randomized Controlled Trial Nested in the CAPRI ...
Ondansetron: Uses, Interactions, Mechanism of Action
Multiday administration of ondansetron has been shown to slow colonic transit in healthy subjects. Ondansetron has no effect on plasma prolactin concentrations.
Application of Intra-articular Corticosteroid Injection in ...
Studies have shown that IACIs apply to any subcategory of juvenile idiopathic arthritis (JIA), especially to JIA with few joints.
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