A Phase IV Study of Cipro XR in Uncomplicated UTI
EXPRESS
EXPRESS: Evaluating Cipro XR Patient Response, Education, Safety, and Satisfaction
1 other identifier
interventional
7,614
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2003
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 17, 2008
CompletedFirst Posted
Study publicly available on registry
April 22, 2008
CompletedDecember 2, 2014
December 1, 2014
April 17, 2008
December 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALInterventions
Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days and brochure about UTI
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Pregnant or nursing
- Complicated UTI
- Allergy to Cipro XR
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2008
First Posted
April 22, 2008
Study Start
February 1, 2003
Study Completion
July 1, 2003
Last Updated
December 2, 2014
Record last verified: 2014-12