Evaluation of CYP4A11 and CYP4F2 Gene Variants as Makers in Edema and Elevated Blood Pressure Occurrence After Nonsteroidal Anti-inflammatory (NSAID) Use
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Edema
研究概览
简要总结
Randomized, double-blinded, cross-over and placebo controlled clinical trial to evaluate the association between genetic polymorphism of CYP4F2 with cardiovascular adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs). Two groups were included according the CYP4F2 V433M genetic polymorphism (control - MM, N=7 vs. VV or VM variants, N=13). According the sample size planned, a mean difference of total body water delta between groups (control vs. polymorphic) of at least allow 10% could be observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers 18-65 years-old -
排除标准
- •Use of drugs and without clinical history of adverse effects of NSAIDS
研究组 & 干预措施
Diclofenac
干预措施: Diclofenac (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Edema
时间窗: after 6 days of diclofenac and placebo
Presence of edema, measured by the estimative of total body water (deuterium oxide dilution technique). The measurements will be done in the end of 6 days of use of placebo and diclofenac, and the delta between diclofenac and placebo will be used as endpoint
次要结局
- Blood Pressure(after 6 days of diclofenac and placebo)
研究者
Eduardo Barbosa Coelho
Associate Professor Nephrology Division - Internal Medicine Dept. Ribeirão Preto Medical School University of São Paulo
University of Sao Paulo