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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
• Treatments: Colchicine

Criteria

Inclusion Criteria:

• Diagnosed with Familial Mediterranean Fever according to Yalcinkaya or

• Tel-Hashomer criteria

• Diagnosis confirmed with the genetic analysis as compound heterozygote or

• homozygote mutation

• Patients between ages of 5-16 and weighted 15-30 kg

• Not received any treatment for FMF

Exclusion criteria:

• Major congenital malformation

• Organ transplantation

• Hepatic disorder

• Chronic kidney disease

• AA amyloidosis

• Thyroid disease

• Rheumatologic disorders other than FMF