NCT01657448已完成3 期
Phase III, Prospective, Multicenter, Single-blind, Randomized, Superiority to Evaluate the Efficacy and Safety of Methenamine Association 250mg + Methylthioninium Chloride 20 mg Compared to Phenazopyridine 100 mg in Symptomatic Control of Dysuria
EMS4 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2016年6月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 316
- 试验地点
- 4
- 主要终点
- Efficacy of treatment in the symptomatic relief of dysuria
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of the combination of Methenamine + Methylthioninium chloride compared to phenazopyridine (comparator product) in the symptomatic relief of dysuria.
详细描述
- Single blind, randomized, prospective study.
- Length of experience: 03 days to 07 days.
- 03 visits (days 1, 4 and 7).
- Evaluation of the efficacy and safety of the medication.
- Shall be assessed for adverse events.
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 (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 who agree to participate by agreeing to the terms proposed in the Clinical trial;
- •Patients aged over 18 years of any ethnicity;
- •Presence of dysuria with marking greater than or equal to 5 measured points on the categorical scale pre-treatment for pain symptom;
排除标准
- •Patients who are febrile (axillary T º: ≥ 38 ° C), with back pain or lumbar;
- •Patients with complicated clinical presentation of urinary tract infection;
- •Patients with a history of allergy or intolerance to any known or suspected one of the ingredients of the product under investigation;
- •Patients who are pregnant or during lactation, or childbearing potential and are not making use of effective contraception;
- •Patients presenting with renal disease or severe liver disease, according to medical history and / or laboratory;
- •Patients presenting with severe systemic disease according to the known medical history;
- •Patients who received antibiotic treatment, anthelmintic within 7 days prior to study entry;
- •Patients unable to understand the guidelines specified in this protocol or can not attend all study visits or unable to complete the log;
- •Pregnancy or risk of pregnancy and lactating patients;
- •Any finding of clinical observation (history and physical examination) that is interpreted by the physician investigator as a risk to the patient's participation in the study.
研究组 & 干预措施
Methenamine, Methylthioninium
Experimental
干预措施: Methenamine and Methylthioninium chloride (Drug)
Phenazopyridine
Active Comparator
干预措施: Phenazopyridine (Drug)
结局指标
主要结局
Efficacy of treatment in the symptomatic relief of dysuria
时间窗: 3 days
次要结局
- Safety of the study medication(7 days)
研究者
研究点 (4)
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