A Multi-Center, Double-Blind, Placebo-Controlled Investigation of Silodosin in the Treatment of Subjects With Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.
研究概览
简要总结
The primary objective is to compare the efficacy of silodosin 4 and 8 mg once daily with placebo in the treatment of subjects with moderate to severe abacterial chronic prostatitis/chronic pelvic pain syndrome during a 12 week treatment period. The secondary objective is to compare the safety of silodosin 4 and 8 mg once daily with placebo.
详细描述
A Multi-Center, Double-Blind, Placebo-Controlled Investigation of Silodosin in the Treatment of Subjects With Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, at least 18 years of age
- •Has a total NIH-CPSI total score of 15
- •Has a NIH-CPSI pain score of 8
- •Has had pain in the pelvic region for at least 3 months prior to screening
排除标准
- •Has previously participated in a Watson study with silodosin
- •Has previously received α-blocked therapy for chronic prostatitis/chronic pelvic pain syndrome or is currently receiving α-blocked therapy for any condition
- •Has experience ≥2 urinary tract infections within the previous 12 months
- •Has any medical condition that in the opinion of the investigator precludes safe participation in the study
- •Has any medical condition that could confound the efficacy evaluation
- •Is receiving ketoconazole, or other known potent inhibitors of cytochrome P450 3A4 or any medication in the opinion of the investigator that precludes safe participation in the study
- •Is receiving any medication that in the opinion of the investigator that could confound the efficacy evaluation
- •Has participated in a study involving the administration of an investigational agent within the past 30 days
研究组 & 干预措施
Silodosin 4 mg
4 mg daily
干预措施: Silodosin 4 mg (Drug)
Silodosin 8 mg
Silodosin 8 mg daily
干预措施: Silodosin 8 mg (Drug)
Placebo
1 placebo capsule daily
干预措施: Placebo (Drug)
结局指标
主要结局
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.
时间窗: 12 weeks
Change from baseline In NIH-CPSI at Week 12. Three separate domain scores are calculated as pain, urinary symptoms, and quality of life impact. NIH-CPSI total score uses a 0 to 43 scale; 0 best, 43 worse symptoms.
次要结局
未报告次要终点