A Phase 2 Randomised, Double-blind, Placebo Controlled, Study of MR901 in Patients With Moderate to Severe Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 225
- 主要终点
- International Prostate Symptoms Score (IPSS) Questionnaire
研究概览
简要总结
This study investigates the safety and efficacy of a photosensitive drug (talaporfin sodium) activated by an intraurethrally placed drug-activating device. MR901 is a code used to identify the combination of talaporfin sodium and the drug-activating device. Two different light doses will be tested against placebo groups in this 4-arm study.
详细描述
At least 192 patients with moderate-to-severe LUTS caused by BPH will be randomized in a 2:2:1:1 ratio to receive a single treatment of talaporfin sodium activated by light at one of two light doses or placebo (saline) with light at either dose. Follow-up is planned for 52 weeks from the day of treatment, with assessment at 12 weeks for change in International Prostate Symptom Score and continued follow-up during the remaining 40 weeks to assess duration of effect, need for any intervention, and longer-term safety.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Talaporfin sodium/Light dose 100 J/cm
Single 1 mg/kg dose of talaporfin sodium is administered intravenously with Drug Activator 100 J/cm delivering light for 60 minutes of the 2-hour treatment period
干预措施: talaporfin sodium (Drug)
Talaporfin sodium/Light dose 100 J/cm
Single 1 mg/kg dose of talaporfin sodium is administered intravenously with Drug Activator 100 J/cm delivering light for 60 minutes of the 2-hour treatment period
干预措施: Drug Activator 100 J/cm (Device)
Talaporfin sodium/Light dose 200 J/cm
Single 1 mg/kg dose of talaporfin sodium is administered intravenously with Drug Activator 200 J/cm delivering light for 2 hours
干预措施: talaporfin sodium (Drug)
Talaporfin sodium/Light dose 200 J/cm
Single 1 mg/kg dose of talaporfin sodium is administered intravenously with Drug Activator 200 J/cm delivering light for 2 hours
干预措施: Drug Activator 200 J/cm (Device)
Saline/Light dose 100 J/cm
0.9% Sodium Chloride is administered intravenously with Drug Activator 100 J/cm delivering light for 60 minutes of the 2-hour treatment period
干预措施: Saline (Drug)
Saline/Light dose 100 J/cm
0.9% Sodium Chloride is administered intravenously with Drug Activator 100 J/cm delivering light for 60 minutes of the 2-hour treatment period
干预措施: Drug Activator 100 J/cm (Device)
Saline/Light dose 200 J/cm
0.9% Sodium Chloride is administered intravenously with Drug Activator 200 J/cm delivering light for 2 hours.
干预措施: Saline (Drug)
Saline/Light dose 200 J/cm
0.9% Sodium Chloride is administered intravenously with Drug Activator 200 J/cm delivering light for 2 hours.
干预措施: Drug Activator 200 J/cm (Device)
结局指标
主要结局
International Prostate Symptoms Score (IPSS) Questionnaire
时间窗: 12 weeks
Change from baseline in the total International Prostate Symptom Score (IPSS, Questions 1-7)
次要结局
- Quality of Life evaluation - BPH Impact Index (BPHII)(4, 12, 26 and 52 weeks)
- Modified International Prostate Symptoms Score (IPSS) Questionnaire(1, 2 and 3 Weeks)
- Patient Global Impression of Improvement (PGI-1)(4, 12, 26 and 52 weeks)
- Clinical Global Impression of Improvement (CGI-1)(4, 12, 26 and 52 weeks)
- Maximum Urinary Flow Rate (Qmax)(1, 2, 3, 4, 12, 26 and 52 weeks)
- Post-void residual volume (PVR volume)(1, 2, 3, 4, 12, 26 and 52 weeks)
- 3-Day Frequency/Volume Data(1, 2, 3, 4, 12, 26 and 52 weeks)
- Safety and tolerability assessed by the number of subjects with Adverse Events(52 weeks)
- Prostate-specific Antigen (PSA)(1, 2, 3, 4, 12, 26 and 52 weeks)
- Duration of effect/time to next treatment and treatment selected(52 weeks)
- International Index of Erectile Function-15 (IIEF-15)(4, 12, 26 and 52 weeks)
- Quality of Life evaluation - Bother Score(1, 2, 3, 4, 12, 26 and 52 weeks)
- Over-active Bladder-V3 (OAB-V3)(1, 2, 3, 4, 12, 26 and 52 weeks)
- International Prostate Symptoms Score (IPSS) Questionnaire(4, 26 and 52 weeks)
- IPSS Subscores.(1, 2, 3, 4, 12, 26 and 52 weeks)
- Prostate volume(Baseline and 12 weeks)