NCT00577967Unknown不适用
Gabapentin - A Solution to Uremic Pruritus? A Prospective, Randomized, Placebo-controlled, Double-blind Study
Hospital Authority, Hong Kong1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2005年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Subjective measurement of reduction in pruritus
研究概览
简要总结
To investigate using the drug gabapentin to relieve the intense pruritic sensation associated with chronic renal failure patients undergoing peritoneal dialysis.
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
- Double
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Chinese male and female patients aged > 18 undergoing CAPD for at least 3 months and able to read and understand Chinese
- •Patients experiencing moderate to severe pruritis, defined as persistent, treatment-resistant pruritis considerably impairing sleep or daytime activity. Treatment resistance is defined as no or only partial resolvement of pruritis under current anti-pruritis treatment regimens such as anti-pruritis lotions and anti-histamines.
- •Patients in stable clinical condition in terms of peritoneal dialysis and general health
- •Patients able to understand and answer the SDS questionnaire
- •Patients able to express the sensation of itchiness in the terms of the VAS and the SDS score
- •Patients who are willing to give written informed consent and to participate in and comply with the study protocol
排除标准
- •Patients with a known history of pruritis or dermatologic disease antedating renal failure.
- •Patients with skin disease other than the usual cutaneous findings of uraemia such as xerosis or ecchymosis.
- •Patients under current treatment with systemic steroids
- •Known history of allergy to Gabapentin
- •Those patients already put on anti-convulsants
- •Unable to give written informed consent for the study
- •Pregnancy or female patients of child-bearing age who are unwilling to use contraception
- •Poor drug compliance
- •Known HIV positivity
- •Active neoplastic disease
- •Those who do not want to participate the study
结局指标
主要结局
Subjective measurement of reduction in pruritus
时间窗: 3 months
次要结局
- Tolerability of Gabapentin in CAPD patients(3 months)
研究者
研究点 (1)
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