Does Allopurinol Prolong a Treated, Acute Gout Flare?
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Does Allopurinol Prolong a Treated, Acute Gout Flare?|
- The Primary Outcome Unit of Measurement is Time (in Days) to Resolution of the Acute Gout Attack [ Time Frame: 1-28 Days ] [ Designated as safety issue: Yes ]
- Change in Patient Rated Pain Over Time [ Time Frame: Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28 ] [ Designated as safety issue: Yes ]Patient rated pain on a Likert pain score of 1-10
- Change in Physician Global Assessment of Gout Activity [ Time Frame: Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28 ] [ Designated as safety issue: Yes ]Physician rated gout activity on a Likert scale 1-10.
- Serum Uric Acid Level [ Time Frame: day 28 ] [ Designated as safety issue: No ]Blood test (serum) for uric acid level
|Study Start Date:||December 2007|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Allopurinol
Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
Placebo Comparator: Sugar pill (Placebo)
Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.
|Drug: Placebo (sugar pill)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01988402
|United States, Texas|
|Wilford Hall Ambulatory Surgical Center|
|Lackland AFB, Texas, United States, 78236|
|Principal Investigator:||Jay B Higgs, MD||Wilford Hall Ambulatory Surgical Center|