TCTR20220322010
Not yet recruiting
Not Applicable
A cross-sectional study to determine the association between the dosage of colchicine and its pharmacokinetic profiles in real practice, and in gouty arthritis patients with varying degrees of renal impairment
aresuan university0 sites300 target enrollmentMarch 22, 2022
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- what is the correct dosage of colchicine in gouty patient who had renal impairment and received medication of dyslipidemia combination in prophylaxis goty flare?
- Sponsor
- aresuan university
- Enrollment
- 300
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.both sex age\>20
- •2\.eGFR change not more than 25% by Cockcroft\-Gault Equation at least 1 month from inform consent
- •3\. diagnosis in primary gout and receive colchicine for goty flare prophylaxis at least 3 month
- •4\. if patients receive dyslipidemia medication (example in atorvastatin , simvastatin) , these medications must stable dosage at least 3 month
- •5\. if patients who received incorrect dosage of colchicine were included in the study and finish in the protocol , the patients were adjusted correctly dosage of colchicine that was adjusted by eGFR. These patients can be included in the trail again, if they finish last protocol at least 4 months after last adjusted correctly dosage of colchicine.
Exclusion Criteria
- •1\. colchicine or component of colchicine allergy
- •2\. the cabnormal of AST, ALT imore than 2 time from normal limit in last atleast 3 months
- •3\. received medication including Strong or moderate cytochrome P450 3A4 inhibitors
- •\- Cobicistat
- •\- Itraconazole
- •\- Ketoconazole
- •\- Voriconazole
- •\- Clarithromycin
- •\- Ciprofloxacin
- •\- Erythromycin
Outcomes
Primary Outcomes
Not specified
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