A Phase IV Study of Cipro XR in Uncomplicated UTI

Official Title: “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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Experimental: Arm 2

Primary Measures

• 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.
  • Time Frame: 3-10 days after start of therapy
    Safety Issue?: No

Secondary Measures

• To examine the difference between physician and patient perceptions of the symptoms of uUTI.
  • Time Frame: At baseline visit pre-therapy
    Safety Issue?: No
• 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.
  • Time Frame: 1-3 days after end of therapy for efficacy and up to 30 days for safety
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Bayer Industry

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00663806

Study ID Number: 100534

ClinicalTrials.gov Identifier: NCT00663806

Health Authority: United States: Institutional Review Board

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