NCT00759135已完成2 期
Phase 2 Multicenter Randomized Two Dose Level and Non-Inferiority Clinical Evaluation of Transrectal Administration of NX-1207 for the Treatment of BPH
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Change in BPH Symptom Score (AUA SI)
研究概览
简要总结
This completed study evaluated the safety and efficacy of two dose levels of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) versus finasteride.
详细描述
Subjects randomized to NX-1207 were blinded as to the dose level of NX-1207 they received.
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
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Documented history of BPH for at least 1 year
- •AUA SI ≥ 15
- •Prostate Volume ≥ 30 mL ≤ 70 mL
- •Qmax < 15 mL/sec
排除标准
- •History of illness or condition that may interfere with study or endanger subject
- •Use of prescribed medications that may interfere with study or endanger subject
- •Presence of a median lobe of the prostate
- •Surgery or MIST in the previous 12 months for treatment of BPH
- •Post-void residual urine volume > 350 mL
- •PSA ≥ 10 ng/mL; prostate cancer must be ruled out for PSA ≥ 4 ng/mL
研究组 & 干预措施
1
Experimental
Single therapeutic dose of 2.5 mg NX-1207
干预措施: 2.5 mg NX-1207 (Drug)
2
Experimental
Single low dose of 0.125 mg NX-1207 for dose-response evaluation
干预措施: 0.125 mg NX-1207 (Drug)
3
Active Comparator
5.0 mg finasteride q.d.
干预措施: finasteride (Drug)
结局指标
主要结局
Change in BPH Symptom Score (AUA SI)
时间窗: 90 days
次要结局
- Change in Prostate Volume(90 days)
- Change in Qmax(90 days)
- Change in BPH Symptom Score (AUA SI)(180 days)
- Number of Participants with Adverse Events, duration and severity of Adverse Events and relation, if any, to drug(180 days)
研究者
研究点 (1)
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