A Randomized, Placebo-controlled, Single-blind, Parallel Design, Multi-center, Phase II Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 8
- 主要终点
- Evaluation of doses of GV1001 by comparing the level of change in IPSS scores in three study groups to a control group.
研究概览
简要总结
This clinical trial is designed as a randomized, placebo-controlled, single-blind, parallel design, multi-center, phase 2 clinical trial to evaluate the efficacy and safety of GV1001 in patients with benign prostatic hyperplasia. Eligible subjects are randomized into a group out of the three study groups and a placebo group after four weeks of placebo run-in period. Placebo run-in period is concurrently proceeded as a wash-out period for previous treatment of benign prostatic hyperplasia, and a placebo is administered intradermally twice with two-week interval during this period. After that, the randomized subjects receive a study drug and a placebo intradermally seven times with two-week interval by visiting at Week 0, 2, 4, 6, 8, 10, and 12. After the treatment period, the subjects additionally visit at Week 13 and 16, and the efficacy is evaluated at Week 4, 8, 12, 13, and 16, and the safety is evaluated over the 16-week period.
详细描述
Patients will be randomized equally between the four arms.
- Control group (placebo, two-week interval): 38 subjects
- Study group 1 (GV1001 0.4 mg, intradermal administration, two-week interval): 38 subjects
- Study group 2 (GV1001 0.56 mg, intradermal administration, two-week interval): 38 subjects
- Study group 3 (GV1001 0.56 mg, intradermal administration, four-week interval): 38 subjects
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
- Single (Participant)
入排标准
- 年龄范围
- 50 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
Control Group
- Placebo, two-week interval, intradermal administration
干预措施: Placebo (Other)
Study Group 1
- GV1001 0.4 mg, two-week interval, intradermal administration
干预措施: GV1001 (Drug)
Study Group 2
- GV1001 0.56 mg, two-week interval, intradermal administration
干预措施: GV1001 (Drug)
Study Group 3
- GV1001 0.56 mg, four-week interval, intradermal administration
: Should be visited every two weeks (GV1001 0.56 mg or placebo is administered alternately at every visit.)
干预措施: Placebo (Other)
Study Group 3
- GV1001 0.56 mg, four-week interval, intradermal administration
: Should be visited every two weeks (GV1001 0.56 mg or placebo is administered alternately at every visit.)
干预措施: GV1001 (Drug)
结局指标
主要结局
Evaluation of doses of GV1001 by comparing the level of change in IPSS scores in three study groups to a control group.
时间窗: at Week 0, 4, 8, 12, 13, and 16
IPSS questionnaire: 7-item questionnaire that measures urinary symptoms, but with an additional, independent eighth question on quality of life. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. The first 7 items has a 6-point response scale (0=none/never to 5=almost always/5 or more times) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). The last item assesses quality of life reported as a Quality of Life assessment index.
次要结局
- Change in volume of prostate gland (TRUS) compared to the baseline(at screening and Week 16)
- Change in International Index of Erectile Function (IIEF) compared to the baseline(at Week 0, 4, 8, 12, 13, and 16)
- Change in maximum flow rate (Qmax) compared to the baseline(at Week 0, 4, 8, 12, 13, and 16)
- Change in prostate-specific antigen (PSA) compared to the baseline(at Week 0, 13, and 16)
- Change in residual urine volume compared to the baseline(at Week 0, 4, 8, 12, 13, and 16)
- Change in hormones (testosterone, DHT) compared to the baseline(at Week 0, 4, 8, 12, 13, and 16)