NCT00821392已完成3 期
A Randomized, Multi-Center, Double Blinded, Allopurinol-Controlled, Placebo-Controlled Parallel Group, 5-Arm, Dose-Response,Bridging Study to Assess the Efficacy and Safety of Febuxostat in Subject 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
- 181
研究概览
简要总结
This study was designed to evalute the efficacy and safety of Febuxostat after oral administration to patientd with gout in Korea
详细描述
This is a multi-center, randomized, double-blind, allopurinol and placebo controlled, parallel, 5 arms, dose response, bridging study of 4 weeks duration.
If subjects pass the screening evaluation after submitting a signed informed consent, they will be randomly assigned to one of the five treatment regimens; febuxostat 40mg, 80mg, 120mg, placebo or allopurinol 300mg. Colchicine 0.6mg QDis given to minimize the risk of gout flares during the washout/run-in period and during the double study period.
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
- Quadruple (Participant, Care Provider, 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
- •<Day -14>
- •age :18-85 years
- •female: either post-menopausal for at least 2 years, surgically sterile, or using a medically accepted means of contraception
- •female: negative serum pregnancy test
- •subjects who satisfy ARA (American Rheumatism Association)
- •subjects must have a renal function defined as: serum creatinine ≤ 1.5 mg/dL <Day -1>
- •1.serum urate level ≥8.0mg/dL 2.creatinine level ≤ 1.5mg/dL 3.subject continued to meet all inclusion and no exclusion criteria
排除标准
- •women who are breast-feeding or pregnant
- •a history of xanthinuria
- •allopurinol intolerance
- •receiving thiazide diuretic therapy
- •secondary hyperuricemia
- •required > 10mg/day of prednisone during the study stable dose(≤10mg/day), inhaled and intranasal steroids will be allowed.
- •concomitant therapy containing aspirin or other salicylates(systemic or topical, prescribed or non-prescribed) stable, low doses aspirin will be allowed(i.e. ≤325mg/day).
- •any change in hormone replacement therapy or oral contraceptive therapy within 3 months of the screening visit
- •alcohol intake≥ 14drinks/week alcohol abuse within 5 years or current excessive alcohol use was prohibited.
- •concomitant therapy with any urate-lowering therapy
- •active liver disease or hepatic dysfunction : ALT, AST ≥1.5 ULN
- •subject was unable to take colchicine or contradictory to colchicine
- •a serum urate level < 8.0mg/dL and not taking uric acid lowering therapy
- •rheumatoid arthritis or any active arthritis requiring for the medication treatment
- •a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the screening visit, or had taken any systemic cancer chemotherapy within 5 years prior to the screening visit
- •participated in another investigational trial within the 30days prior to the screening visit
- •any other significant medical condition as defined by the investigator
研究组 & 干预措施
1 Febuxostat 40mg
Active Comparator
干预措施: Febuxostat (Drug)
2 Febuxostat 80mg
Active Comparator
干预措施: Febuxostat (Drug)
3 Febuxostat 120mg
Active Comparator
干预措施: Febuxostat (Drug)
4 Allopurinol 300mg
Sham Comparator
干预措施: Febuxostat (Drug)
5 Placebo
Placebo Comparator
干预措施: Febuxostat (Drug)
研究者
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