NCT00533910已完成不适用
Effect of Rifaximin on Driving Performance, Psychometric Test Performance and Quality of Life in Cirrhotic Patients With Minimal Hepatic Encephalopathy: Randomized, Double-blind, Placebo-controlled Trial.
Hunter Holmes Mcguire Veteran Affairs Medical Center1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2007年10月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Driving Performance
研究概览
简要总结
The purpose of this study is to determine whether alteration of gut flora with rifaximin can lead to improvement in driving performance, psychometric test performance, and quality of life in patients with minimal hepatic encephalopathy (MHE) and cirrhosis in a randomized, blinded, placebo-controlled trial.
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
- Triple (Participant, Care Provider, 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
- 否
入选标准
- •Age 18-65 years
- •Cirrhosis diagnosed on clinical grounds
- •MHE diagnosed by abnormalities in a psychometric battery (NCT-A, NCT-B, ICT BDT and DST impaired beyond 2 standard deviations of known control values on any of the above 3 tests will be considered to have MHE)
- •Current drivers (valid driving license and driving at least 20 miles/week)
- •All women of child-bearing potential will be required to use effective contraception
排除标准
- •Current or recent (< 6 month) use of alcohol (AUDIT questionnaire will be used; any cirrhotic with a value of > 0 will be excluded) and a positive blood alcohol level
- •Use of antibiotics within last 6 weeks
- •Allergy to rifaximin, rifabutin, rifampin, or rifapentine
- •Infection or gastrointestinal hemorrhage within the last 6 weeks
- •Renal insufficiency
- •Hepatocellular carcinoma
- •Psychoactive drug use, including interferon concurrently
- •Non-drivers and those who drive less than 20 miles/week
- •Pregnancy and breastfeeding
- •Excluding patients with OHE:
- •Detailed neurological examination to check for dysarthria, asterixis, ataxia and disorientation
- •Detailed history-taking from friends/relatives only after taking the patient's permission
- •Mini-mental status examination > 25
- •Episode of overt (clinical hepatic encephalopathy) within 6 months
- •Current treatment with lactulose, rifaximin, zinc, or metronidazole
研究组 & 干预措施
Placebo
Placebo Comparator
Will be given placebo and follow the exact procedures as the experimental section
干预措施: placebo (Drug)
Drug
Experimental
干预措施: Rifaximin (Drug)
结局指标
主要结局
Driving Performance
时间窗: 8 weeks
Total driving errors at the end of drug/placebo. Minimum is zero, maximum is not defined. Higher number indicates greater errors.
次要结局
- Total Sickness Impact Profile Score(8 weeks)
- Psychometric Test Performance(8 weeks)
研究者
Jasmohan Bajaj
Associate Professor of Medicine
Hunter Holmes Mcguire Veteran Affairs Medical Center
研究点 (1)
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