A Phase IV Study of Cipro XR in Uncomplicated UTI

Phase 4

Completed

• Conditions: Urinary Tract Infections
• Interventions: Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939)

• Registration Number: NCT00663806
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study Completion: 2003-07
• Study First Submitted: 2008-04-17
• Study First Submitted QC: 2008-04-21
• Study First Posted: 2008-04-22
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7614

Inclusion Criteria

• 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.

Exclusion Criteria

• Pregnant or nursing
• Complicated UTI
• Allergy to Cipro XR

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Cipro XR (Ciprofloxacin, BAYQ3939)	-
Arm 1	Cipro XR (Ciprofloxacin, BAYQ3939)	-

Primary Outcome Measures

Name	Time	Method
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.	3-10 days after start of therapy

Secondary Outcome Measures

Name	Time	Method
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