NCT01966614已完成3 期
Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of a Single Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (The PLUS 1 Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 479
- 主要终点
- Efficacy
研究概览
简要总结
The purpose of this study is to evaluate the safety 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥50 years
- •Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months
- •Maximum urine flow (Qmax) of 5 - 15 mL/sec
- •Prostate volume of 30 - 100 mL as determined by TRUS
- •Serum prostate-specific antigen (PSA) values <10 ng/mL
- •Post-void residual (PVR) <= 200 mL
排除标准
- •Inability to void ≥125 mL urine
- •Prior surgery/MIST for BPH
- •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
Placebo
Placebo Comparator
Placebo (Vehicle-only injection)
干预措施: Placebo (Other)
PRX302
Experimental
PRX302 injection
干预措施: PRX302 (Drug)
结局指标
主要结局
Efficacy
时间窗: Week 52
International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks.
次要结局
- Safety(Week 52)
- Efficacy(Week 52)
研究者
相似试验
已完成
2 期
Transperineal Intraprostatic Injection of PRX302 Under Ultrasound Guidance for Management of Prostatic HyperplasiaBenign Prostatic HyperplasiaNCT00889707Sophiris Bio Corp92
已完成
2 期
Intraprostatic PRX302 Injection to Treat Localised Prostate CancerProstate CancerNCT03081481Sophiris Bio Corp38
已完成
2 期
Evaluate, Safety and Tolerability of Intraprostatic PRX302 Administration, Low to Intermediate Risk Prostate CancerProstate CancerNCT02499848Sophiris Bio Corp18
终止
2 期
Study of PRX-03140 Monotherapy in Subjects With Alzheimer's DiseaseAlzheimer's DiseaseNCT00693004Epix Pharmaceuticals, Inc.236
已完成
3 期
Safety and Efficacy Study Evaluating TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)Behavioral Variant Frontotemporal Dementia (bvFTD)NCT01626378TauRx Therapeutics Ltd220