Does Allopurinol Prolong a Treated, Acute Gout Flare?
Status: | Completed |
---|---|
Conditions: | Gout |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/16/2018 |
Start Date: | December 2007 |
End Date: | June 2013 |
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.
during a treated acute gout attack will have any effect on the duration of the attack.
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.
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.
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
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