A Randomized Open Label Dose Determination Clinical Study to Evaluate the Safety and Efficacy of Capsule Outflo in Patients with Benign Prostatic Hyperplasia.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 6
- 主要终点
- Change in International Prostate Symptom Score (IPSS)
研究概览
简要总结
This study is a randomized, open label, multi-centric trial comparing the safety and efficacy of Capsule OutFlo (1 BD) and OutFlo (2 BD) 75 patients with Benign Hyperplasia of Prostate. The primary outcome of the trial is to compare the decrease in IPSS in patients taking OutFlo (1BD) vs. OutFlo (2 BD) . Primary outcome measures would also include change in Qmax and post void residual urine volume. Reduction in Prostate size from the base-line to the end of the study would be noted as a secondary outcome measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •â€¢Male patients with aged ≥40 •New patients diagnosed with BPH, naïve to any other treatments for BPH •Patients with International Prostate Symptom Score (IPSS) greater than 7 and less than 18 •Patients with Prostate volume less than 40 cc •Patients with Qmax of 8-12 ml/sec •Patients with PVUR less than 200 ml •Patients willing to give written informed consent and willing to follow up.
排除标准
- •â€¢Patients with prostatic cancer; neurogenic bladder; bladder cancer; bladder stones; urethral strictures; neurological conditions that might interfere with normal voiding •Symptomatic coronary arterial disease, stroke, and cardiovascular events •Current treatment with systemic corticosteroids or herbal (alternative) medicines •Patients with abnormal renal and hepatic function •Any significant disease or disorder that may jeopardize the safety of the subject •Patients with drug and alcohol abuse •Any psychiatric disorder •Patients who have participated in any clinical trial in the past 3 months.
结局指标
主要结局
Change in International Prostate Symptom Score (IPSS)
时间窗: Change in International Prostate Symptom Score (IPSS)(baseline - 1 month - 2 months - 3months) | Change in Uroflowmetry parameters (baseline - 1 month - 2 months - 3months)
Change in Uroloflowmetry parameters
时间窗: Change in International Prostate Symptom Score (IPSS)(baseline - 1 month - 2 months - 3months) | Change in Uroflowmetry parameters (baseline - 1 month - 2 months - 3months)
次要结局
- Change in Prostate Volume(Baseline - End of Study)