TCTR20220322010Not yet recruitingNot 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 enrollmentStarted: March 22, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 21 Years to N/A (No limit) (—)
- Sex
- All
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
- •- Fluconazole
- •- Cimetidine
- •- Verapamil
- •- Diltiazem
- •- Cyclosporine
- •AND P-glycoprotein inhibitors
- •- Amiodarone
- •- Carvedilol
- •- Quinidine
- •- Clarithromycin
- •- Itraconazole
- •- Ranolazine
- •- Verapamil
- •within 14 day before including in the study
- •4. blood loss or donate blood component more than 300 cc. within 1 month before including in the study
- •5. gouty patients with HIV positive or cirrhosis or organ transplant or cancer were excluded
- •6. pregnancy test positive
Investigators
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