Wilford Hall Ambulatory Surgical Center
Lackland Air Force Base, Texas, 78236, United States
NCT Number: NCT01988402
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Lackland Air Force Base, Texas, 78236, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
requires both of:
Plus one of the following:
Exclusion criteria
Time frame: 1-28 Days
The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack
Time frame: Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported
Patient rated pain on a Likert pain score of 0-10
Time frame: Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported
Physician rated gout activity is measured on a Likert scale 0-10.
Time frame: day 28
Blood test (serum) for uric acid level
59th Medical Wing
Fed
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