A Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS-2 in Treating Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment Naïve Male Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- Changes in total International Prostate Symptom Scores (I-PSS)
研究概览
简要总结
The hypothesis of the study is to examine whether MCS-2 is safe and effective in the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.
详细描述
Eligible male subjects will be randomized to receive either MCS-2 or placebo for 12 weeks. Subjects are those not currently on any medicines for BPH or LUTS. During and at the end of the 12-week treatment period, randomized subjects will be evaluated for efficacy and safety parameters. All subjects will be advised to maintain a normal diet, similar to what was consumed before joining the study.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≧ 40 years old.
- •Not being treated for BPH or LUTS.
- •PSA ≦ 4 ng/ml and no pathologically-proven prostate cancer.
- •I-PSS ≥ 10
- •No known malignancy
- •AST/ALT ≦ 3X UNL.
- •Creatinine ≦ 3X UNL.
- •Subjects who sign the informed consent form.
排除标准
- •Subjects' LUTS are not BPH-related
- •Have been treated with pelvis irradiation or pelvic surgery.
- •Plan to undergo any invasive procedures within the study period.
- •Active infection or inflammation.
- •Considered ineligible by the investigators.
研究组 & 干预措施
MCS-2
Drug Name: MCS-2 Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks
干预措施: MCS-2 (Drug)
Placebo
Drug Name: MCS-2 placebo Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in total International Prostate Symptom Scores (I-PSS)
时间窗: 12 weeks
Changes in total International Prostate Symptom Scores (I-PSS)
次要结局
- Changes in I-PSS quality of life index(12 weels)
- Changes in I-PSS subscores(12 weeks)
- Changes in urinary peak flow rate(12 weeks)
- Incidence of treatment-emergent adverse events(12 weeks)
- Incidence of withdrawals due to treatment-emergent adverse events(12 weeks)