Phase 4
Completed N=35
Does Allopurinol Prolong a Treated, Acute Gout Flare?
Source: ClinicalTrials.gov NCT01988402 ↗Enrolled (actual)
35
Serious AEs
8.6%
Results posted
Jan 2015
Primary outcomePrimary: Resolution of the Acute Gout Attack — 15.4; 13.4 days — p=0.5
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resolution of the Acute Gout Attack |
15.4; 13.4 | 0.5 |
| SECONDARY Pain Day 28 |
1.79; 2.0 | — |
| SECONDARY Physician Global Assessment of Gout Activity at Day 28 |
0; 0 | — |
| SECONDARY Serum Uric Acid Level |
6.4; 8.2 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01988402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.