Clinical Study to Compare The Safety and Possible Efficacy of Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Kidney Disease Quality of Life Short Form (KDQOL-SF™)
研究概览
简要总结
Several studies investigated the effectiveness of Gabapentin in Uremic Pruritus (UP). No previous studies investigated the use of fexofenadine in UP. The aim of this trial is to assess the safety and possible efficacy of fexofenadine in patients with UP.
详细描述
A randomized controlled single center parallel study, that will recruit 60 participants with end stage renal disease (ESRD) on regular hemodialysis (RHD) with uremic pruritus (UP). Patients will be randomized to either Fexofenadine (60 mg orally once daily), or Gabapentin (100 mg orally after each dialysis session, "thrice weekly", with titration according to response to 100 mg orally once daily). Participants will continue treatment for 3 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •ESRD on regular hemodialysis.
- •Moderate and severe Uremic Pruritus as assessed by Visual Analogue Scale.
- •Able to provide an informed consent.
排除标准
- •Age < 18 years old.
- •Patients not on regular hemodialysis.
- •Pruritus due to other cause.
- •Cancer patients.
- •Pregnancy or breastfeeding.
- •Patients with history of substance abuse.
- •Patients with myasthenia gravis.
- •Patients who refuse or are unable to provide an informed consent.
研究组 & 干预措施
Group 1: (Gabapentin group)
30 patients will receive Gabapentin 100 mg after each dialysis session (thrice weekly). Dose may be titrated after 2 weeks, according to response and tolerability, to 100 mg orally once daily for 3 months.
干预措施: Gabapentin (Drug)
Group 2: (Fexofenadine group)
30 patients will receive Fexofenadine 60 mg orally once daily for 3 months.
干预措施: Fexofenadine (Drug)
结局指标
主要结局
Kidney Disease Quality of Life Short Form (KDQOL-SF™)
时间窗: 3 months
The change in mean KDQOL-SF score from baseline.
The Visual Analogue Scale (VAS)
时间窗: 3 months
The change in mean score of Visual Analogue Scale (VAS) from baseline.
Skindex score
时间窗: 3 months
The change in mean Skindex score from baseline.
次要结局
- Substance P(3 months)
- Interleukin-6 (IL-6)(3 months)
研究者
Mohamed Ihab Hosny Mohamed Elfalaha
Pharmacist
Tanta University