NCT01391325已完成4 期
Long-term Allopurinol Safety Study Evaluating Outcomes in Gout Patients (LASSO)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,735
- 主要终点
- Safety of Allopurinol
研究概览
简要总结
This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy (ULT) for up to six months. Allopurinol will be dosed according to the local product label, at the discretion of the Investigator, to achieve an optimal, medically appropriate dose for each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Meets the diagnosis of gout according to the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
- •Not on a urate lowering therapy (ULT) must have an sUA level ≥ 8.0 mg/dL at screening.
- •If on concomitant ULT must have an sUA level ≥ 6.5 mg/dL at screening.
- •Must have had at least 2 gout flares in the past year.
排除标准
- •Consumption of more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
- •History or suspicion of drug abuse.
- •History of autoimmune disease requiring systemic treatment.
- •Known or suspected human immunodeficiency virus (HIV), hepatitis C antibody (HCV), or hepatitis B antibody (HBsAg) infection.
- •History of malignancy within the previous 5 years (with the exception of nonmelanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer).
- •Myocardial infarction, unstable angina, New York Heart Association (NYHA) class III or IV heart failure, or stroke within the last 12 months.
- •Uncontrolled hypertension (systolic pressure above 160 mm Hg or diastolic pressure above 95 mm Hg).
- •Estimated creatinine clearance < 30 mL/min by Cockcroft-Gault formula.
- •Kidney or other organ transplant.
- •Active peptic ulcer disease requiring treatment.
- •History of xanthinuria, active liver disease, or hepatic dysfunction.
- •If unable to take gout flare prophylaxis of either colchicine or nonsteroidal anti-inflammatory drugs (NSAIDs) due to contraindication (e.g. toxicity, renal function, use of contraindicated medications).
- •Known hypersensitivity or allergy to allopurinol.
研究组 & 干预措施
Allopurinol
Other
Treatment.
干预措施: Allopurinol (Drug)
结局指标
主要结局
Safety of Allopurinol
时间窗: Every month for 6 months.
Proportion of subjects who experienced at least one Treatment Emergent Adverse Event (TEAE) during the study.
次要结局
- Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL(Month 6)
- Incidence of Gout Flares(Every month for 6 months.)
- Mean Change From Baseline to Month 6 in SF-36 PCS+MCS(Month 6)
研究者
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