Does Allopurinol Prolong a Treated, Acute Gout Flare?

Phase 4

Completed

Brief Summary: This is a double blind placebo controlled study to determine whether starting allopurinol during a treated acute gout attack will have any effect on the duration of the attack.

Detailed Description: Traditional teaching holds that starting allopurinol during an acute gout attack will prolong the attack. Recent expert opinion from the American College of Rheumatology Guidelines is that allopurinol may be started during an acute, treated gout attack. This study is designed to test the hypothesis that allopurinol does not prolong an acute, treated gout attack. Patients will either take allopurinol capsules or and identical capsule containing no allopurinol (placebo) over 28 days, starting within 72 hours of a gout attack that is being treated with other standard measures. During the study, neither the patient nor the examiner will know what pills are being taken. The time to resolution of the attack is the primary outcome measure. Pain level, serum uric acid level, and complications of therapy will also be monitored. A minimum of 32 patients completing the study are needed for a meaningful conclusion.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Inability to return for examinations
Glomerular filtration rate (calculated) less than 50 milliliters per minute
Allopurinol use in past 6 months
Ongoing cancer therapy
Concomitant azathioprine or cyclophosphamide
Any one of the following liver enzymes greater than 1.25 times the upper limit of normal:
- AST [Aspartate aminotransferase]
- ALT [Alanine aminotransferase]
- alkaline phosphatase
Pre-gout pain in involved joint of more than 3 on a scale of 1-10
Neurologic deficit around the involved joint

Arm && Interventions

Group	Intervention	Description
Allopurinol	allopurinol	Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
Sugar pill (Placebo)	Placebo (sugar pill)	Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.

Primary Outcome Measures

Name	Time	Method
Resolution of the Acute Gout Attack	1-28 Days	The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack

Secondary Outcome Measures

Name	Time	Method
Physician Global Assessment of Gout Activity at Day 28	Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported	Physician rated gout activity is measured on a Likert scale 0-10.
Pain Day 28	Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported	Patient rated pain on a Likert pain score of 0-10
Serum Uric Acid Level	day 28	Blood test (serum) for uric acid level