A comparative, single blind, parallel group, non-crossover, multi-centric trial of Silodosin Capsules 4 mg, with Urief Capsules, in-patients suffering from dysurea associated with benign prostatic hyperplasia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- A comparative evaluation of efficacy of Silodosin Capsules 4 mg, with Urief Capsules, in-patients suffering from dysurea associated with benign prostatic hyperplasia.
研究概览
简要总结
This syudy is a comparative, single blind, parallel group, non-crossover, multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Silodosin Capsules 4 mg Vs Urief Capsules, in 200, in patients suffering from dysurea associated with benign prostatic hyperplasia. Date of enrollment is 07 December 2009.
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Out come will be measured at Day 0, 1 week, 2 week, 4 week, 6 week, 8 week and 12 week. in patients suffering from dysurea associated with benign prostatic hyperplasia. The efficacy parameters will primarily focus on improvement in the clinical signs & symptoms like Blood in the urine, Dribbling after voiding, Frequent urination, Hesitant, interrupted, or weak urine stream and Recurrent, sudden, urgent need to urinate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 75.00 Day(s)（—）
- 性别
- Male
入选标准
- •Male patients between 40 and 75 years of age
- •Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
- •Patient with signs and symptoms of Dysurea Associated with benign prostatic hyperplasia, diagnosed clinically.
排除标准
- •Patients <40 & > 75 years.
- •Patients with hypersensitivity to the drug.
- •Concomitant illness
- •Patients who have participated in a drug study in the past 3 months.
- •Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits
- •Use of enzyme-modifying drugs within 30 days prior to day 1 of this study.
- •HIV and Australian Antigen positive subjects.
- •Significant history or presence of glaucoma, cardiovascular or hematological disease.
- •Any condition which are likely to hinder the compliance with the protocol.
结局指标
主要结局
A comparative evaluation of efficacy of Silodosin Capsules 4 mg, with Urief Capsules, in-patients suffering from dysurea associated with benign prostatic hyperplasia.
时间窗: Day 0, 1 week,2 week, 4 week,6 week, 8 week and 12 week.
The efficacy parameters will primarily focus on improvement in the clinical signs & symptoms like Blood in the urine, Dribbling after voiding, Frequent urination, Hesitant, interrupted, or weak urine stream and Recurrent, sudden, urgent need to urinate.
时间窗: Day 0, 1 week,2 week, 4 week,6 week, 8 week and 12 week.
次要结局
- A comparative evaluation of safety & tolerability of Silodosin Capsules 4 mg, with Urief Capsules, in-patients suffering from dysurea associated with benign prostatic hyperplasia.(Day 0, 1 week,)