NCT01310673

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

Therapy for Acute Gout: Does Initial Use of Allopurinol Effect Duration and/or Recurrence Rate of Acute Attacks

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: White River Junction Veterans Affairs Medical Center · Federal
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gout
• Gout Acute

Interventions

Type	Name	Description
DRUG	Allopurinol	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.
DRUG	Placebo	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.

Timeline

• Start date: 1998-01-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2011-03-08
• Last updated: 2011-03-08

Locations

1 site across 1 country: United States