A Phase IV Study of Cipro XR in Uncomplicated UTI
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Tract Infections
Intervention: Cipro XR (Ciprofloxacin, BAYQ3939) (Behavioral); Cipro XR (Ciprofloxacin, BAYQ3939) (Behavioral)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
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.
Clinical Details
Official title: EXPRESS: Evaluating Cipro XR Patient Response, Education, Safety, and Satisfaction
Study design: Other, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: To examine the difference between physician and patient perceptions of the symptoms of uUTI.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.
Detailed description:
Safety and efficacy of Cipro XR in a naturalistic setting and the effectiveness of an
educational brochure.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Additional Information
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Starting date: February 2003
Ending date: July 2003
Last updated: April 21, 2008
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