Clinical trial NCT01988402: Does Allopurinol Prolong a Treated, Acute Gout Flare?
Official title: Does Allopurinol Prolong a Treated, Acute Gout Flare?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gout
Keywords: gout
allopurinol
Lead sponsor: 59th Medical Wing
Sponsor class: FED
Collaborators: name: United States Air Force
First posted: 2013-11-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Resolution of the Acute Gout Attack
timeFrame: 1-28 Days
Secondary outcomes:
measure: Pain Day 28
timeFrame: Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported
measure: Physician Global Assessment of Gout Activity at Day 28
timeFrame: Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported
measure: Serum Uric Acid Level
timeFrame: day 28
Other outcomes:
Locations:
city: Lackland Air Force Base
country: United States
facility: Wilford Hall Ambulatory Surgical Center
state: Texas
Study officials:
affiliation: 59th Medical Wing
name: Jay B Higgs, MD
role: PRINCIPAL_INVESTIGATOR
References: