Phase II, Dose-Response, Safety and Efficacy Study of Oral TMX-67 in Subjects With Gout.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 主要终点
- Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit.
研究概览
简要总结
The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in reducing serum urate levels in subjects with gout.
详细描述
Gout is a chronic urate crystal deposition disorder, which if left untreated may result in progressive disease characterized by joint and bone destruction from tophaceous deposits and renal impairment due to gouty nephropathy. Hyperuricemia, defined as a serum urate concentration of >7.0 milligrams per deciliter (mg/dL), is the underlying metabolic aberration leading to urate crystal deposition in gout. Gout has several clinical presentations, including: recurrent acute attacks of inflammatory arthritis; deposition of monosodium urate monohydrate crystals in joints, bones and even parenchymal organs (tophaceous gout); renal impairment; and uric acid nephrolithiasis. As serum urate levels increase beyond >7.0 mg/dL, the risks for gouty arthritis or for renal calculi increase.
Currently allopurinol is the only xanthine oxidase inhibitor available. Allopurinol is the agent of choice for reduction of serum urate levels in patients with: uric acid overproduction; unresponsive or intolerant to uricosuric agents; impaired renal function; uric acid urolithiasis; or tophi.
Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients 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
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hyperuricemia (serum uric acid ≥8.0 mg/dL).
- •Must meet American College of Rheumatology criteria for gout.
- •Must have adequate renal function (serum creatinine <1.5 mg/dL).
- •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.
排除标准
- •History of xanthinuria
- •Alcohol consumption >14/week
- •Has a history of significant concomitant illness.
- •Has active liver disease.
- •Has a body mass index greater than 50 kilogram per meter² (kg/m²)
- •Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator.
研究组 & 干预措施
Placebo QD
干预措施: Placebo (Drug)
Febuxostat 40 mg QD
干预措施: Febuxostat (Drug)
Febuxostat 80 mg QD
干预措施: Febuxostat (Drug)
Febuxostat 120 mg QD
干预措施: Febuxostat (Drug)
结局指标
主要结局
Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit.
时间窗: Day 28.
Serum urate values were obtained at the Day 28 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 28 visit was summarized.
次要结局
- Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit.(Day 7.)
- Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit.(Day 14.)
- Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit.(Day 21.)
- Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit.(Baseline and Day 7.)
- Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit.(Baseline and Day 14.)
- Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit(Baseline and Day 21.)
- Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit.(Baseline and Day 28.)
- Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period.(Baseline and Any visit (Day 7, 14, 21,or 28))
- Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28.(Baseline and Day 28.)