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To Compare benefit of two doses of a drug folinic acid in patients who develop harmful effects due to overdose of the drug methotrexate

Randomized Controlled Trial to compare two different doses of Folinic acid (leucovorin) in Methotrexate Toxicity - FLIMT

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021152
Enrollment
60
Registered
2019-09-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: T451- Poisoning by, adverse effect of and underdosing of antineoplastic and immunosuppressive drugs

Interventions

Intervention1: folinic acid usual dose: folinic acid (leucovorin) 15 mg e very 6 hours intravenous till hematologic recovery or 10 days whichever is less Control Intervention1: folinic acid higher dos

Sponsors

PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 A patient prescribed weekly or the biweekly dose of tablet or parenteral Methotrexate (up to 50 mg per week) for rheumatic or dermatologic or gastrointestinal disease 2 Patient having methotrexate hematologic Toxicity defined as EITHER WBC less than 2000 AND OR Platelet count less than 50000 per microlitre (with or without mucositis) 3 Either inadvertent overdose OR renal dysfunction

Exclusion criteria

Exclusion criteria: 1 Patient not consenting for the study 2 Patient being treated with High Dose Methotrexate regimen. 3 Patient 4 Patient already received more than one dose of folinic acid

Design outcomes

Primary

MeasureTime frame
Hematologic recovery: platelet atleast 1,00,000/dl AND WBC atleast 4000 per ulTimepoint: 5 and 10 days

Secondary

MeasureTime frame
DeathTimepoint: 10 days;Diarrhea recoveryTimepoint: 5 and 10 days;Mucositis recoveryTimepoint: 5 and 10 days

Countries

India

Contacts

Public ContactDr Mudit Bhargava

Post Graduate Institute of Medical Education and Research

varundhir@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 11, 2026