The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Symptomatic Non-complicated Urinary Tract Infection in Females
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Number of participants with storage symptoms
研究概览
简要总结
The efficacy of Solifenacin Succinate 5 mg as adjuvant therapy and levofloxacin (500 mg) for short-term treatment to reduce symptoms in patients with symptomatic non complicated urinary tract infection in females.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •females (18-65 years old)
- •dysuria in symptomatic non complicated urinary tract infection
排除标准
- •Pediatric Patients (< 18 years old)
- •geriatric Patients (> 65 years old)
- •pregnant Patients
- •Patients with complicated urinary tract infection
- •sexually transmitted infections
- •Patients with pathological abnormalities in the urinary bladder, including stone/mass
- •Catheter-mounted
- •Neurological diseases/disorders
- •patients with allergy/hypersensitivity with Levofloxacin/Solifenacin
研究组 & 干预措施
levofloxacin and solifenacin succinate
Levofloxacin 500 mg tablet and solifenacin succinate 5 mg tablet by mouth once daily for 3 days
干预措施: Levofloxacin (Drug)
levofloxacin and solifenacin succinate
Levofloxacin 500 mg tablet and solifenacin succinate 5 mg tablet by mouth once daily for 3 days
干预措施: Solifenacin succinate (Drug)
levofloxacin and placebo
Levofloxacin 500 mg tablet and placebo (for solifenacin succinate) by mouth once daily for 3 days
干预措施: Levofloxacin (Drug)
levofloxacin and placebo
Levofloxacin 500 mg tablet and placebo (for solifenacin succinate) by mouth once daily for 3 days
干预措施: Placebo (for Solifenacin succinate) (Drug)
结局指标
主要结局
Number of participants with storage symptoms
时间窗: up to three days
次要结局
未报告次要终点
研究者
Harrina Erlianti Rahardjo,MD,PhD
MD, PhD
Dr Cipto Mangunkusumo General Hospital