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Safety and efficacy study of different dosage colchicine versus celecoxib prophylaxis in gout patients commencing urate lowering therapy

Safety and efficacy study of different dosage colchicine versus celecoxib prophylaxis in gout patients commencing urate lowering therapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101746
Enrollment
Unknown
Registered
2025-04-29
Start date
2025-05-06
Completion date
Unknown
Last updated
2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gout

Interventions

Group A:colchicine 0.5mg qd
Group B:colchicine 0.5mg bid
Group C:celexicob 200mg qd

Sponsors

the affiliated hospital of qingdao university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. >18 years old; 2. Serum urate >420 umol/L; 3. eGFR>60 ml/min/1.73m^2; 4. Given informed consent. 5. Agree to start febuxostat

Exclusion criteria

Exclusion criteria: 1. Contraindications or intolerance to febuxostat; 2. Patients with severe tophi and chronic gouty arthritis with no remission period, or are experiencing flare. 3. Contraindications to colchicine or celecoxib; 4. Biliary tract diseases: biliary tract malformations, cholelithiasis, acute and chronic cholecystitis, cholangitis; 5. Digestive diseases: constipation, obstruction, digestive ulcer active stage patients; 6. Abnormal thyroid function; 7. eGFR < 60ml/min/1.73m^2 or serum creatinine (Cr) =177umol/L; 8. Patients with severe heart disease, such as decompensated heart failure (NYHA stage III and IV); Unstable angina pectoris; History of myocardial infarction within the past 12 months; 9. Patients with xanthinuria; 10. Rheumatoid arthritis or other arthritis disease; 11. Currently using azathioprine, 6-mercaptopurine, cyclosporine, cyclophosphamide, bisazinamide, sulfamethoxazole, trimethoprim, theophylline, thiazide diuretics, aspirin (more than 325mg/ day) or other salicylic acid drugs, losartan, intravenous colchicine treatment; 12. Patients with secondary gout caused by blood disease, kidney disease or tumor radiotherapy and chemotherapy; 13. Brain disease, abnormal judgment ability; Mental illness can not cooperate; 14. Alcohol or drug abuse; 15. Participants who had participated in other clinical trials within three months before the screening of this trial; 16. Malignant tumor, active tuberculosis; 17. Complicated with other diseases, and researchers believe that affect the efficacy evaluation or poor compliance; 18. Taking glucocorticoid drugs; 19. White blood cell count < 4.0×10^9/L, or platelets < 100×10^9/L, or hemoglobin < 90g/L; 20. For any other reason that the researcher considers it inappropriate to participate in the experiment.

Design outcomes

Primary

MeasureTime frame
mean number of gout flares between 0 and 6 months;

Secondary

MeasureTime frame
proportion of patients with a flare;time to first flare;proportion of patients with >=1 and >=2 gout flares;

Countries

China

Contacts

Public ContactChanggui Li

the affiliated hospital of qingdao university

lichanggui@medmail.com.cn+86 532 8291 2015

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026