CTRI/2019/09/021152
Completed
Phase 3
Randomized Controlled Trial to compare two different doses of Folinic acid (leucovorin) in Methotrexate Toxicity - FLIMT
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- PGIMER Chandigarh
- Enrollment
- 38
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •1 Patient not consenting for the study
- •2 Patient being treated with High Dose Methotrexate regimen.
- •3 Patient \<12 years of age
- •4 Patient already received more than one dose of folinic acid
Outcomes
Primary Outcomes
Not specified
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