NCT01451645已完成4 期
Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 主要终点
- Number of Gout Flares Per Participant From Day 1 to Week 16
研究概览
简要总结
The purpose of this study is to determine if once-daily treatment with colchicine, compared to placebo, is effective in preventing gout flares in patients who are initiating therapy with allopurinol.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria include, but are not limited to the following:
- •Men and postmenopausal women between the ages of 18 and 70
- •Meets the ARA criteria for classification of acute gout
- •Tophi present and/or a history of gout attacks in 2 or 3 joints
- •Self-reported history of at least 2 gout flares in the prior 12 months
- •Serum uric acid greater than or equal to 7.5 mg/dL at the first visit
排除标准
- •Exclusion criteria include, but are not limited to the following:
- •Patients with an acute gout flare within 2 weeks prior to the first visit
- •Patients with chronic, active gout with at least 1 continuously inflamed joint for at least 4 weeks
- •Patients with more than three joints affected by gout
- •History of intolerance or allergy to colchicine or allopurinol
- •Use of allopurinol, benzbromarone, febuxostat, probenecid, or sulfinpyrazone less than 3 months prior to entering the study
- •Use of colchicine less than 14 days prior to entering the study
研究组 & 干预措施
Colchicine (Colcrys®)
Active Comparator
daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
干预措施: Colchicine (Colcrys®) (Drug)
placebo
Other
daily placebo dosing for 16 weeks with background allopurinol therapy
干预措施: placebo (Drug)
placebo
Other
daily placebo dosing for 16 weeks with background allopurinol therapy
干预措施: allopurinol (Drug)
Colchicine (Colcrys®)
Active Comparator
daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
干预措施: allopurinol (Drug)
结局指标
主要结局
Number of Gout Flares Per Participant From Day 1 to Week 16
时间窗: Day 1 to Week 16
次要结局
- Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16(Day 1 to Week 16)
- Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16(Day 1 to Week 16)
- Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16(Day 1 to Week 16)
研究者
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