Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
Colchicine is widely recognized as safe and effective treatment of Familial Mediterranean
Fever (FMF) in children and adults. Colchicine is currently used to treat FMF in younger
patients by inexact dosing through breaking or crushing adult-dose tablets. An
age-appropriate sprinkle formulation will allow for more accurate dosing in pediatric
patients. The primary objective of this study is to evaluate and compare the steady-state
pharmacokinetics of multiple oral doses of colchicine sprinkle capsules administered to
pediatric and adult FMF patients.
Secondary objectives include evaluation of the safety and tolerability of this regimen in
pediatric and adult FMF patients and measurement of the levels of acute phase reactants (i.e,
serum amyloid A [SAA], erythrocyte sedimentation rate [ESR], C-reactive protein [CRP]) at
baseline and after dosing.