Does Allopurinol Prolong a Treated, Acute Gout Flare?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Resolution of the Acute Gout Attack
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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
研究组 & 干预措施
Allopurinol
Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
干预措施: allopurinol (Drug)
Sugar pill (Placebo)
Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.
干预措施: Placebo (sugar pill) (Drug)
结局指标
主要结局
Resolution of the Acute Gout Attack
时间窗: 1-28 Days
The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack
次要结局
- Physician Global Assessment of Gout Activity at Day 28(Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported)
- Pain Day 28(Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported)
- Serum Uric Acid Level(day 28)
研究者
Jay B. Higgs, MD
Program Director, Rheumatology Fellowship
59th Medical Wing