Does Allopurinol Prolong a Treated, Acute Gout Flare?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does Allopurinol Prolong a Treated, Acute Gout Flare?

Conditions
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Gout

Intervention / Treatment
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* Drug: allopurinol
* Drug: Placebo (sugar pill)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria requires both of: Crystal proven gout, and An acute gout attack within 72 hours of first treatment Plus one of the following: At least 2 gout attacks in past 12 months Tophus Nephrolithiasis 24hr urine uric acid greater than 1000mg 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Allopurinol<br>Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days | Drug: allopurinol<br> <br> |
| Placebo Comparator: Sugar pill (Placebo)<br>Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days. | Drug: Placebo (sugar pill)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of the Acute Gout Attack | The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack | 1-28 Days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gout, allopurinol