A Phase IV Study of Cipro XR in Uncomplicated UTI (EXPRESS)

EXPRESS: Evaluating Cipro XR Patient Response, Education, Safety, and Satisfaction

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939); Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939)

• Study Type: Interventional
• Enrollment (Actual): 7614
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939); Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days and brochure about UTI; Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939); Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days; not given brochure about UTI
Experimental: Arm 2	Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939); Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days and brochure about UTI; Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939); Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days; not given brochure about UTI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: February 1, 2003
• Study Completion (Actual): July 1, 2003

Study Registration Dates

• First Submitted: April 17, 2008
• First Submitted That Met QC Criteria: April 21, 2008
• First Posted (Estimate): April 22, 2008

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: December 1, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: UTI
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: 100534