The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With FMF
Status:
Completed
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
Summary
It was aimed to examine the efficacy and safety of once daily dosage schema of colchicine in
pediatric patients with FMF compared to twice daily dosage schema.
In this 24-week, multicentric, randomized, controlled, noninferiority trial, pediatric
patients newly diagnosed with FMF, carrying homozygote or compound heterozygote mutation and
did not receive any treatment, were included. Patients were randomly assigned using block
randomization method to receive treatment with once or twice daily doses. Clinical and
laboratory characteristics and medication side effects were recorded and compared between
groups. The study complied with Good Clinical Practice and the Consolidated Standards for
Reporting of Trials (CONSORT) statement.
Phase:
Phase 4
Details
Lead Sponsor:
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi