NCT01454349已完成1 期
A Randomized Dose-Escalation, Multicenter Safety and Efficacy Study of a Single Transrectal Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 15
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and efficacy of a single treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months
- •Written informed consent prior to enrollment in the study
- •Prostate volume of 30 - 100 mL as determined by TRUS
- •Maximum urine flow (Qmax) of 4 - 15 mL/sec
- •Refractory, intolerant or refused the use of alpha-blockers and/or 5 alpha-reductase inhibitors
- •Unwilling or unable to undergo conventional surgical or available minimally invasive treatments
- •Blood PSA values <10 ng/mL
排除标准
- •Inability to void at least 125 mL of urine
- •PVR volume >200 mL
- •Presence of or history of certain conditions that could interfere with study results or endanger subject
- •Use of certain prescribed medications that could interfere with study results
研究组 & 干预措施
PRX302
Experimental
干预措施: PRX302 (Drug)
Inactive substance
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety
时间窗: Month 3
Safety of PRX302
Tolerability
时间窗: Month 3
Tolerability of PRX302
次要结局
- Efficacy(Month 12)
- Tolerability(Month 12)
- Pharmacokinetics(Day 1)
- Safety(Month 12)
研究者
研究点 (15)
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