NCT00756171已完成2 期
Colesevelam Versus Placebo in Cholestatic Pruritus. A Double-blind, Placebo-controlled Study
Foundation for Liver Research3 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- 40% reduction of pruritus according to visual analogue scores
研究概览
简要总结
38 patients with pruritus due to chronic cholestatic liver disease will be evaluated in an investigator initiated, multicenter, double-blind, placebo-controlled, 3-week study assessing the effects of colesevelam on pruritus. Colesevelam is an oral, non-absorbable bile-acid sequestrant much more potent than cholestyramine but free of adverse effects. It is registered as a lipid lowering agent. The intensity of symptoms will be scored by means of daily Visual Analogue Scales (VAS). Fatigue, quality of life and cutaneous scratch lesions will also be evaluated using quantitative instruments.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with pruritus as a result of a cholestatic disorder
- •age above 18 years
- •informed consent
排除标准
- •use of cholestyramine
- •pregnancy
- •inability to understand or speak Dutch language
- •malignancy/life expectancy <6 months
研究组 & 干预措施
1
Experimental
Verum; colesevelam
干预措施: colesevelam (Drug)
2
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
40% reduction of pruritus according to visual analogue scores
时间窗: 3 weeks
次要结局
- improvement in quality of life scores(3 weeks)
- Reduction in pruritus score/scratch lesions(3 weeks)
研究者
研究点 (3)
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