NCT00663806已完成4 期
EXPRESS: Evaluating Cipro XR Patient Response, Education, Safety, and Satisfaction
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 7,614
- 主要终点
- To compare the effect on knowledge of uncomplicated urinary tract infection (uUTI) in patients who were given a disease-directed educational brochure to read versus patients who were not given the brochure.
研究概览
简要总结
Safety and efficacy of Cipro XR in a naturalistic setting and the effectiveness of an educational brochure. - Women with urinary tract infections were treated with Cipro XR. They were also given a brochure with information about urinary tract infections and later tested on the information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •Ambulatory women outpatients 18 to 65 years of age with a documented clinical diagnosis of uUTI characterized by dysuria with either urgency or frequency. Women of childbearing age were enrolled only if they were highly unlikely to conceive during the study and were practicing a suitable method of birth control or were at least 1 year postmenopausal.
- •Positive leukocyte esterase (>/= 1+) and positive nitrite test using a urine dipstick method of analysis.
- •Willing to give written consent.
排除标准
- •Pregnant or nursing
- •Complicated UTI
- •Allergy to Cipro XR
结局指标
主要结局
To compare the effect on knowledge of uncomplicated urinary tract infection (uUTI) in patients who were given a disease-directed educational brochure to read versus patients who were not given the brochure.
时间窗: 3-10 days after start of therapy
次要结局
- To examine the difference between physician and patient perceptions of the symptoms of uUTI.(At baseline visit pre-therapy)
- To collect data on the clinical efficacy and safety of Cipro XR, 500 mg, PO once daily, for 3 days, in the treatment of uUTI in a naturalistic setting.(1-3 days after end of therapy for efficacy and up to 30 days for safety)
研究者
相似试验
已完成
3 期
Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract InfectionsUrinary Tract InfectionNCT00668122Bayer212
已完成
4 期
Cipro® XR in Therapeutic Response and Activity (eXtRa) - Assessing Symptom Relief in Urinary Tract InfectionsUrinary Tract InfectionNCT00676533Bayer276
已完成
4 期
Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Urinary Tract InfectionsUrinary Tract InfectionNCT00669994Bayer180
已完成
4 期
Study To Evaluate The Efficacy And Safety Of Ciprofloxacin Extended-Release (Cipro® XR) 1000 mg Tablets Given Once Daily For 7 To 14 Days In The Treatment Of Patients 18 Years Or Older With Complicated Urinary Tract Infections Caused By Pseudomonas Aeruginosa And Other Common UropathogensUrinary Tract InfectionsNCT00481689Bayer500
已完成
1 期
Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/MesalamineHealthyNCT01402947Shire30