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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 November 2015 |
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Main ID: |
NCT02602028 |
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Date of registration:
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05/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With FMF
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Scientific title:
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The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With Familial Mediterranean Fever: A Randomized Trial |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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79 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02602028 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Erkan Demirkaya, MD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gulhane Military Medical Academy |
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Name:
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Cengizhan Acikel, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gulhane Military Medical Academy |
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Key inclusion & exclusion criteria
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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
Age minimum:
5 Years
Age maximum:
16 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Familial Mediterranean Fever
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Intervention(s)
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Drug: colchicine
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Primary Outcome(s)
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Mor severity scoring system
[Time Frame: At baseline and every 12 weeks, up to 24 weeks. Change in disease severity as assessed by the Mor severity scoring system.]
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Adverse events
[Time Frame: up to 24 weeks]
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Secondary Outcome(s)
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Number of Participants With Abnormal Laboratory Values
[Time Frame: At baseline and every 12 weeks, up to 24 weeks.]
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Secondary ID(s)
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1491-1437-11/1539
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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