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
- 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?colchicine, gout, renal impairment, dosage, pharmacokinetic
- Registration Number
- TCTR20220322010
- Lead Sponsor
- aresuan university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 300
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.
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method dosage of colchicine after stable dosage of colchicine at least 3 month in the screening date and plasma concentration before and after 2 hour in the includsion date Plasma concentration,recommendation of colchicine dosage in gouty patients who had renal impairment after stable dosage of colchicine at least 3 month in the screening date and plasma concentration before and after 2 hour in the includsion date population pharmacokinetics model,predictive model for dose colchcine by predictive method analysis after stable dosage of colchicine at least 3 month in the screening date and plasma concentration before and after 2 hour in the includsion date prdictive model
- Secondary Outcome Measures
Name Time Method pattern of colchicine dosage in patients who had renal impairment after stable dosage of colchicine at least 3 month in the screening date percent ratio,activate PBMC in cochicine multiple level in WBC after stable dosage of colchicine at least 3 month in the screening date and plasma concentration before and after 2 hour in the includsion date stimulate by cystral and inflammasome response