Trial | NCT01310673  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    allopurinol ...

  • Study Participants

    57
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.
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.
Study Started
Jan 31
1998
Primary Completion
Jul 31
2009
Study Completion
Jul 31
2009
Last Update
Mar 08
2011
Estimate

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.

Allopurinol Active Comparator

Placebo Placebo Comparator

Criteria 

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
No Results Posted