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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gout, Gout Acute

Intervention / Treatment
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* Drug: Allopurinol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Allopurinol<br> | Drug: Allopurinol<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily pain scores and recurrence attack rate. | Daily pain measured on a visual analogue scale over 10 days after initiation of treatment. Patient reported gout recurrences over 30 days | 30 days after initiation of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sedimentation rates and C-reactive protein at 0, 3, 10, and 30 day visits | Fall in ESR and CRP were measured as confirmation of attack resolution | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gout, Allopurinol, Acute gout