NCT01736514已完成3 期
A Randomized, Open Label, Multicenter, Allopurinol- Controlled Study to Assess the Safety and Efficacy of Oral Febuxostat in Patients With Gout
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 109
- 主要终点
- Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL
研究概览
简要总结
This is a multicenter, open label, randomized, allopurinol-controlled, parallel-design study. Approximately 120 subjects will be randomly assigned in 1:1 ratio to receive febuxostat, or allopurinol for subjects with 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
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will also have a history or presence of gout as defined by the American College of Rheumatology (ACR) criteria
- •Subject has serum urate level >= 8.0 mg/dL at the screening Visit
排除标准
- •Female subject who is breast-feeding or pregnant
- •Subject has a history of xanthinuria
- •Subject who is intolerant of allopurinol, ie hypersensitivity, Steven-Johnson syndrome/topic epidermal necrolysis
- •Subject who takes allopurinol > 300 mg/day and with serum urate level > 8mg/dL
- •Subject who is HLA B*5801 positive
- •Subject who is receiving thiazide diuretic therapy
- •Subject who has secondary hyperuricemia
- •Subject who requires concurrent therapy with any systemic or topical medications, prescribed or non-prescribed, containing aspirin or other salicylates (low doses of aspirin will be allowed(ie. =< 325mg/day)
- •Subject who requires therapy with prednisone > 10 mg/ day during the study
- •Subject who has active liver disease or hepatic dysfunction, defined as both ALT and AST > 1.5 times the upper limit of normal
- •Subject who has serum creatinine >= 1.5mg/dL
- •Subject who has any another significant medical condition as defined by the investigator that would interfere with the treatment, safety or compliance with the protocol (eg. A clinically significant ECG result)
- •Subject who has a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the study, or has taken any systemic cancer chemotherapy within 5 years prior to the study
- •Subject who has previously participated in a clinical study in which febuxostat was administered
- •Subject who has participated in another investigational trial within the 30 days prior to the study
研究组 & 干预措施
febuxostat group
Experimental
oral
干预措施: febuxostat (Drug)
allopurinol group
Active Comparator
oral
干预措施: Allopurinol (Drug)
结局指标
主要结局
Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL
时间窗: week 12
次要结局
- Safety assessed by the incidence of adverse events, physical exam. and vital signs, tabo-tests and 12-lead ECG(Baseline and at week 12)
- Percent reduction in serum urate levels(Baseline and at week 12)
研究者
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