NCT01109121已完成2 期
A Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Tranilast in Combination With Allopurinol in Patients With Moderate to Severe Gout (TAnGO)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Percent change from baseline in serum uric acid (sUA) levels
研究概览
简要总结
This Phase 2 study will be a multicenter, double-blind, randomized, active-comparator study to evaluate the safety and efficacy of tranilast in combination with allopurinol in patients with hyperuricemia and moderate to severe gout.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 to 80
- •Severe gout, demonstrated by 3 or more gout flares in the previous 12 months, or the presence of at least one gout tophus or gouty arthritis
- •Hyperuricemia with a sUA ≥8.0 mg/dL
排除标准
- •Pregnant or nursing
- •Known hypersensitivity to any of the components of tranilast or allopurinol
- •Known history of xanthinuria or kidney stones
- •Use of an investigational drug within 30 days
- •Presence of, or history of, cancer with the exception of completely excised, non-metastatic squamous cell and basal cell carcinomas of the skin
- •Subject is planning or likely to require a surgical procedure during the study
研究组 & 干预措施
Allopurinol
Active Comparator
Allopurinol
干预措施: Allopurinol (Drug)
Combination 400
Experimental
Tranilast and Allopurinol
干预措施: Combination 400 (Drug)
Combination 600
Experimental
Tranilast and Allopurinol
干预措施: Combination 600 (Drug)
结局指标
主要结局
Percent change from baseline in serum uric acid (sUA) levels
时间窗: 4 weeks
次要结局
- Proportion of subjects whose sUA levels fall below 6.0 mg/dL following 4 weeks of dosing(4 weeks)
研究者
研究点 (1)
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