Initiation of Allopurinol at First Medical Contact for Acute Attacks of Gout

White River Junction Veterans Affairs Medical Center

Status and phase: Completed; Phase 4

Conditions: Gout; Gout Acute

Treatments: Drug: Placebo; Drug: Allopurinol

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01310673

CPHS #16820

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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57 participants in 2 patient groups, including a placebo group

Allopurinol

Active Comparator group

Treatment:

Drug: Allopurinol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo