check_circleStudy Completed
Urinary Tract Infections
Bayer Identifier:
100534
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A Phase IV study of Cipro XR in uncomplicated UTI
Trial purpose
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.
Key Participants Requirements
Sex
FemaleAge
18 - 65 YearsTrial summary
Enrollment Goal
7614Trial Dates
February 2003 - July 2003Phase
Phase 4Could I Receive a placebo
NoProducts
Cipro XR (Ciprofloxacin, BAYQ3939)Accepts Healthy Volunteer
NoPrimary 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.date_rangeTime Frame:3-10 days after start of therapyenhanced_encryptionnoSafety Issue:
Secondary Outcome
- To examine the difference between physician and patient perceptions of the symptoms of uUTI.date_rangeTime Frame:At baseline visit pre-therapyenhanced_encryptionnoSafety Issue:
- 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.date_rangeTime Frame:1-3 days after end of therapy for efficacy and up to 30 days for safetyenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
BehavioralTrial Purpose
OtherAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2