Phase III Clinical Study, Prospective, Multicenter, Double-blind, Randomized, Double-dummy to Assess the Efficacy and Safety of "Pílulas de Lussen®" Compared to the Pyridium® in the Symptomatic Control of Dysuria
试验速览
- 阶段
- 3 期
- 入组人数
- 80
- 主要终点
- Visual Analogic Scale and opinion of the investigator.
研究概览
简要总结
Clinical Study, prospective, comparative, randomized, double-dummy entry with random from a total of 80 patients, 40 patients will receive the test medication (Pílulas de Lussen®) plus placebo and 40 patients will receive the comparative (Pyridium®) plus placebo.
详细描述
Phase III Clinical Study, prospective, multicenter, double-blind, randomized, double-dummy to assess the efficacy and safety of "Pílulas de Lussen®" compared to the Pyridium® in the symptomatic control of dysuria in 80 patients of either sex or race, older than 18 years, with symptoms of dysuria, 40 patients will receive the test medication (Pílulas de Lussen®) plus placebo and 40 patients will receive the comparative (Pyridium®) plus placebo to evaluate the effectiveness and tolerability of 'Pílulas de Lussen' for symptomatic relief of dysuria.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 18 years;
- •Patients with symptoms of dysuria characterized by pain/burning sensation in the lower urinary tract and discomfort in urination;
- •Patients who are female and are of childbearing age should use reliable method of contraception and have negative pregnancy test.
- •Patients who consent to participate in the study.
排除标准
- •Patients with sensitivity to any component of the formula;
- •Patients pregnant or lactating;
- •Patients with a history of glaucoma, heart failure, cardiac arrhythmias, prostatic hypertrophy, paralytic ileus or pyloric stenosis;
- •Patients with menorrhagia or heavy menstrual periods;
- •Patients who need to use antibiotics or chemotherapy;
- •Patients who can not follow the procedures shown in this Clinical Protocol.
研究组 & 干预措施
Pílulas de Lussen
Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days.
* Drug A: Pílulas de Lussen®
** Drug B: placebo.
干预措施: Pílulas de Lussen (Drug)
Pyridium®
Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days.
* Drug A: Pyridium®
** Drug B: placebo.
干预措施: Pyridium® (Drug)
结局指标
主要结局
Visual Analogic Scale and opinion of the investigator.
时间窗: 3 days
次要结局
- Of adverse events related to study medication by the Naranjo Algorithm.(3 days)