Does Allopurinol Prolong a Treated, Acute Gout Flare?

59th Medical Wing

Status and phase: Completed; Phase 4

Conditions: Gout

Treatments: Drug: allopurinol; Drug: Placebo (sugar pill)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01988402

FWH20070235H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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35 participants in 2 patient groups, including a placebo group

Allopurinol

Active Comparator group

Description:

Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days

Treatment:

Drug: allopurinol

Sugar pill (Placebo)

Placebo Comparator group

Description:

Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.

Treatment:

Drug: Placebo (sugar pill)