Early versus Late Allopurinol Initiation in an Acute Gout Attack: A Randomized Controlled Trial (ELAG)

Not Applicable

Recruiting

• Conditions: acute gout attack within 72 hours after onset; Allopurinol, Initiation, Gout, Gout outcome.

• Registration Number: TCTR20190223001
• Lead Sponsor: avamindradhiraj University Research Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-23
• Study Completion: 2020-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

Patients > 18 years old presented with an acute gout attack within 72 hours after onset, and crystal-proven gout by arthrocentesis founded MSU crystals
and at least one of the following
- Frequent attack ≥ 2/year, tophi by clinical exam or imaging study, CKD stage 2 or worse (Estimated Glomerular Filtration Rate < 90 ml/min/1.73m2 ), past urolithiasis, serum uric acid > 8 mg/dL during attack or comorbidities (at least one of following; hypertension, ischemic heart disease or congestive heart failure)

Exclusion Criteria

1. CKD stage 5 (eGFR < 15) or on Renal replacement therapy
2. Prior use of uric lowering agents past month
3. History of adverse reactin to allopurinol or colchicine
3. Ongoing cancer treatment
4. concomitant use of azathioprine or cyclosporin
5. taking xanthine oxidase inhibitor or uricosuric agent withih 1 month
6. AST, ALTand/or ALP level more than 2 times of upper normal limit
7. Neurologic deficit resulting in decreased pain sensatin around the involve joints
8. During intubation
9. Inability to return for examinations
10. presence of HLA-B*5801 genes

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
time to complete resolution of acute gouty attack between early and late initiation of allopurinol 5 visit (day1, day5-9, day 14, day 19-23 and day28) visual analog scale and physical examination

Secondary Outcome Measures

Name	Time	Method
time to clinical resolution of the acute gout attack between early and late allopurinol group 5 visit (day1, day5-9, day 14, day 19-23 and day28) visual analog scale ,relapse of arthritis 5 visit (day1, day5-9, day 14, day 19-23 and day28) questionaire,Laboratory parameter (Serum uric acid,eGFR, ESR, CRP) 3 visit (day1, day 14, and day28) blood test