A Double-Blind, Randomized, Placebo-Controlled Trial of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Prostatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 283
- 主要终点
- The change in total NIH-CPSI score from baseline to Week 12
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of ELMIRON® in the treatment of chronic non-bacterial inflammation of the prostate gland.
详细描述
The objective of this randomized, double-blind, placebo-controlled study is to determine the effectiveness and safety of ELMIRON® 100 mg three times per day for 12 weeks, as compared with placebo, in patients with chronic non-bacterial inflammation of the prostate gland. Safety evaluations will be assessed throughout the study. The hypothesis of the study is that ELMIRON® will be more effective than placebo, as based on the change in the total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score from baseline to the final visit (Week 12) and is generally well-tolerated. Patients will receive oral ELMIRON® 100 mg three times per day orally or matching placebo three times per day for 12 weeks.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic non-bacterial prostatitis/chronic pelvic pain syndrome
- •symptoms of discomfort or pain in the perineal and/or pelvic region (lower abdomen) for at least three of the last six months for which there is no recognized cause
- •symptoms persist despite treatment with antibiotics for non-bacterial prostatitis in the past six months.
排除标准
- •Clinically significant medical problems or other organ abnormalities
- •psychiatric disorders
- •urinary tract infection during the last three months
- •history of bladder, urethral or prostate cancer
- •Prostate Specific Antigen (PSA) greater than or equal to 4 ng/mL
- •diagnosis or treatment for genital herpes or herpes flare within the last year.
研究组 & 干预措施
001
pentosan polysulfate sodium
干预措施: pentosan polysulfate sodium (Drug)
结局指标
主要结局
The change in total NIH-CPSI score from baseline to Week 12
次要结局
- Participant-reported Global Response Assessment at Week 12. Brief Male Sexual Function Index at Weeks 4, 8, and 12. Pelvic Pain Urgency and Frequency symptom scale at Weeks 4, 8, and 12.