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The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With FMF

NCT02602028 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2015-11-11

No results posted yet for this study

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.

Conditions

  • Familial Mediterranean Fever

Interventions

DRUG

colchicine

to compare once daily dosage schema of colchicine and twice daily dosage schema of colchicine

Sponsors & Collaborators

  • Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

    lead OTHER

Principal Investigators

  • Erkan Demirkaya, MD, MSc · Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

  • Cengizhan Acikel, MD, MPH · Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-04-30
Completion
2013-08-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02602028 on ClinicalTrials.gov