Gout, Gout Acute
Conditions
Keywords
Gout, Allopurinol, Acute gout
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.
Interventions
DRUGAllopurinol
Allopurinol 300mg po QD for 30 days. Indomethacin 50mg TID for 10 days. Colchicine 0.6mg po Bid or QD, as tolerated for 90 days.
DRUGPlacebo
Placebo tablet QD for 10 days, followed by delayed allopurinol 300mg po QD days 11-30. Indomethacin 50mg TID for 10 days. Colchicine 0.6mg po Bid or QD, as tolerated for 90 days.
Sponsors
White River Junction Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed