An Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Study to Establish the Dosage, Efficacy, and Safety of MCS-2 in Treating Lower Urinary Tract Symptoms Suggestive of BPH in Treatment-Naive Male Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Changes from baseline in International Prostate Symptom Scores
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
This is an adaptive trial design, that combines elements of a Phase 2b (dose ranging) study and a Phase 3 (hypothesis testing) study, the objectives for the two phases are separate.
Phase 2b Objectives: The primary objective of the Phase 2b portion of this study is to evaluate, in a treatment-naïve population, the 0 mg (placebo), 15 mg, and 30 mg MCS-2 in terms of dose response and to determine the optimal dose to be used in the Phase 3 portion of this trial. The secondary objective of this portion of the study is to evaluate the safety and tolerability of the 15 mg and 30 mg MCS-2.
Phase 3 Objectives: The primary objective of the Phase 3 portion of this study is to evaluate, in a treatment-naïve population, the effectiveness of the MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg), in reducing the lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). The secondary objective of this study is to evaluate the safety and tolerability of MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg).
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
Placebo
Both the phase 2b and phase 3 parts of the study have the placebo arm.
干预措施: Placebo (Drug)
MCS-2 15 mg/day
For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 15 mg/day is selected as the optimal dosage.
干预措施: MCS-2 15 mg/day (Drug)
MCS-2 15 mg/day
For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 15 mg/day is selected as the optimal dosage.
干预措施: MCS-2 30 mg/day (Drug)
MCS-2 30 mg/day
For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 30 mg/day is selected as the optimal dosage.
干预措施: MCS-2 15 mg/day (Drug)
MCS-2 30 mg/day
For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 30 mg/day is selected as the optimal dosage.
干预措施: MCS-2 30 mg/day (Drug)
结局指标
主要结局
Changes from baseline in International Prostate Symptom Scores
时间窗: 12 weeks
次要结局
- Changes in I-PSS subscores(12 weeks)
- Changes in I-PSS QOL index(12 weeks)
- Changes in urine flow rate(12 weels)
- Incidence of treatment-emergent adverse events (TEAE)(12 weeks)
- Incidence of withdrawals due to TEAEs(12 weeks)