NCT03129295Unknown2 期
A Randomized, Double-Blind, Placebo-Controlled, MultiCenter Study of the Efficacy and Safety of MPC-SHRC for the Relief of Symptoms Associated With Uncomplicated Urinary Tract Infections
Mission Pharmacal4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Change from baseline on assessment instrument
研究概览
简要总结
A study of the efficacy and safety of MPC-SHRC for the relief of symptoms associated with uncomplicated urinary tract infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-pregnant, nonlactating woman with moderate to severe symptoms of urinary tract infection
- •On adequate birth control
- •Normal ECG
排除标准
- •Participated in any other trial within 30 days of visit 1
- •Known or suspected allergy to investigational drug
- •Narrow angle glaucoma
- •Recovering from chicken pox or flu-like symptoms
- •History of peptic ulcer, gastrointestinal bleeding, gastrointestinal surgery, or gastrointestinal dysfunction which could interfere with drug absorption
- •Taken any drugs for within past 24 hours for symptoms associated with uncomplicated urinary tract infections
- •Currently taking prohibited drugs
- •Taken an antibiotic within 7 days of Visit 1
- •Are ineligible to receive an antibiotic
- •History of urinary retention
- •History of interstitial cystitis
- •History of impaired renal function
- •History of impaired hepatic function
- •Diagnosis or suspicion of complicated urinary tract infection or systemic infection
- •History of substance abuse
研究组 & 干预措施
MPC-SHRC
Experimental
oral tablet four times a day for 3 days
干预措施: MPC-SHRC (Drug)
Placebo
Placebo Comparator
oral tablet four times a day for 3 days
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Change from baseline on assessment instrument
时间窗: 6 hours after the first dose of study drug
Patient reported outcome
次要结局
- Change from baseline on assessment instruments(Three hour intervals after first dose of study drug)
- Change from baseline on Pain Scale(Three hour intervals after first dose of study drug)
研究者
研究点 (4)
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