Initiation of Allopurinol at First Medical Contact for Acute Attacks of Gout
- Registration Number
- NCT01310673
- Brief Summary
Medical teaching suggests allopurinol should not be initiated in the setting of an acute attack of gout, as rapid lowering of serum urate may exacerbate the attack. This study tests the hypothesis that there is no difference in patient reported daily pain or flair occurrences with early versus delayed institution of allopurinol during an acute gout attack.
- Detailed Description
Design: Randomized, placebo-controlled, double-blind trial. Setting: Outpatient clinics, White River Junction Veterans Affairs Medical Center.
Patients: 57 men with crystal proven acute gout attack, at first medical contact, and within 7 days onset.
Intervention: Subjects were randomized to receive allopurinol 300mg daily or matching placebo for 10 days. All patients received indomethacin 50mg TID for 10 days, prophylactic dose colchicine 0.6mg BID for 90 days, and open-label allopurinol starting at day 11.
Measurements: Primary outcomes were patient reported pain on visual analogue scale (VAS) for the primary joint, and self reported flares in any joint days 1-30. Secondary endpoints included urate, sedimentation rates, C-reactive protein levels.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 57
- First medical contact for acute attack of gout.
- ACR criteria for acute attack of gout
- Crystal proven by arthrocentesis on day of enrollment
- Primary gout
- Secondary Gout
- Tophaceous Gout
- Prior steroid, colchicine, or uric acid lowering therapy in the past 6 months.
- Uncontrolled CHF
- Unstable angina
- Renal insufficiency (entry CREAT > 1.3)
- Anticoagulant therapy
- Immunosuppressive therapy or chemotherapy in the past 6 months
- Pregnancy; OR
- Known allergy to NSAID, colchicine, or allopurinol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Allopurinol Allopurinol - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Daily pain scores and recurrence attack rate. 30 days after initiation of treatment Daily pain measured on a visual analogue scale over 10 days after initiation of treatment.
Patient reported gout recurrences over 30 days
- Secondary Outcome Measures
Name Time Method sedimentation rates and C-reactive protein at 0, 3, 10, and 30 day visits 30 days Fall in ESR and CRP were measured as confirmation of attack resolution
Trial Locations
- Locations (1)
White River Junction VA Medical Center
🇺🇸White River Junction, Vermont, United States