A Phase IV Study of Cipro XR in Uncomplicated UTI

Urinary Tract Infections Clinical Trial

— EXPRESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663806
• Other study ID #: 100534
• Status: Completed
• Phase: Phase 4
• First received: April 17, 2008
• Last updated: December 1, 2014
• Start date: February 2003
• Est. completion date: July 2003

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7614
• Est. completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

Behavioral:
• Cipro XR (Ciprofloxacin, BAYQ3939)
Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days and brochure about UTI
• Cipro XR (Ciprofloxacin, BAYQ3939)
Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days; not given brochure about UTI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To examine the difference between physician and patient perceptions of the symptoms of uUTI.		At baseline visit pre-therapy	No
Secondary	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	Yes

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