Febuxostat (Zurig) Efficacy & Safety Trial in Comparison With Allopurinol in Hyperuricemic Subjects With or Without Gout
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Serum uric acid levels
研究概览
简要总结
Febuxostat is a potent, nonpurine, selective inhibitor of Xanthine oxidase that exhibits antihyperuricemic activity by reducing the formation of uric acid. The investigators conducted an interventional, two-arm, randomized, open label pilot study on patients with serum urate level ≥ 6.8 mg/dL. Patients were treated with Febuxostat 40 mg Tablets or Allopurinol 300 mg Tablets once daily dose for 90 days to determine the efficacy and safety of Febuxostat in comparison with Allopurinol in Hyperuricemic Subjects with or without Gout.
详细描述
Patients with hyperuricemia (with or without Gout) were randomized into two groups. One was treated with Febuxostat 40 mg Tablets and other with Allopurinol 300 mg Tablets once daily for 3 months period.
Gender, age, height, weight, creatinine and ALT levels, co-morbidities and other complications were monitored at screening and as per eligibility criteria 50 patients were enrolled in the study. Efficacy was determined by monitoring serum uric acid levels during and at the end of treatment. The safety profile has also been monitored during the treatment period. Investigator collected and recorded all the data of visits in CRF which was analyzed through SPSS version 20.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders from 18 to 75 years of age
- •Must have a serum urate level ≥ 6.8 milligram per deciliter (mg/dL) and/or subjects recruited with Gout; must meet American College of Rheumatology criteria for Gout.
- •Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- •Patient willingly provides written informed consent
排除标准
- •History of significant concomitant illness
- •Active liver disease (SGPT> 1.5 times the upper limit of normal range)
- •Severe renal impairment (Serum Creatinine level >2mg/dl)
- •Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator
- •Cardiac disease or stroke (current or previous history)
- •Has a known history of infection with hepatitis B, hepatitis C, or HIV
- •Has a history of cancer within 5 years prior to the first dose of study medication
- •Has a known hypersensitivity to febuxostat or allopurinol or any components of their formulation
研究组 & 干预措施
Allopurinol
Allopurinol 300mg Tablets once daily for 90 days
干预措施: Allopurinol (Drug)
Febuxostat
Febuxostat 40mg Tablets once daily for 90 days
干预措施: Febuxostat (Drug)
结局指标
主要结局
Serum uric acid levels
时间窗: 3 months
To determine the efficacy of Febuxostat once daily with Allopurinol once daily in hyperuricemic subjects for 3 months
次要结局
- Safety Assessment: number of participant with adverse events(At week 2, week 4 and week 12)