Therapy for Acute Gout: Does Initial Use of Allopurinol Effect Duration and/or Recurrence Rate of Acute Attacks
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Daily pain scores and recurrence attack rate.
研究概览
简要总结
Medical teaching suggests allopurinol should not be initiated in the setting of an acute attack of gout, as rapid lowering of serum urate may exacerbate the attack. This study tests the hypothesis that there is no difference in patient reported daily pain or flair occurrences with early versus delayed institution of allopurinol during an acute gout attack.
详细描述
Design: Randomized, placebo-controlled, double-blind trial. Setting: Outpatient clinics, White River Junction Veterans Affairs Medical Center.
Patients: 57 men with crystal proven acute gout attack, at first medical contact, and within 7 days onset.
Intervention: Subjects were randomized to receive allopurinol 300mg daily or matching placebo for 10 days. All patients received indomethacin 50mg TID for 10 days, prophylactic dose colchicine 0.6mg BID for 90 days, and open-label allopurinol starting at day 11.
Measurements: Primary outcomes were patient reported pain on visual analogue scale (VAS) for the primary joint, and self reported flares in any joint days 1-30. Secondary endpoints included urate, sedimentation rates, C-reactive protein levels.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •First medical contact for acute attack of gout.
- •ACR criteria for acute attack of gout
- •Crystal proven by arthrocentesis on day of enrollment
- •Primary gout
排除标准
- •Secondary Gout
- •Tophaceous Gout
- •Prior steroid, colchicine, or uric acid lowering therapy in the past 6 months.
- •Uncontrolled CHF
- •Unstable angina
- •Renal insufficiency (entry CREAT > 1.3)
- •Anticoagulant therapy
- •Immunosuppressive therapy or chemotherapy in the past 6 months
- •Pregnancy; OR
- •Known allergy to NSAID, colchicine, or allopurinol
研究组 & 干预措施
Allopurinol
干预措施: Allopurinol (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Daily pain scores and recurrence attack rate.
时间窗: 30 days after initiation of treatment
Daily pain measured on a visual analogue scale over 10 days after initiation of treatment. Patient reported gout recurrences over 30 days
次要结局
- sedimentation rates and C-reactive protein at 0, 3, 10, and 30 day visits(30 days)