check_circleStudy Completed

Urinary Tract Infections

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

Female

Age

18 - 65 Years

Trial summary

Enrollment Goal
7614
Trial Dates
February 2003 - July 2003
Phase
Phase 4
Could I Receive a placebo
No
Products
Cipro XR (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteer
No

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.
    date_rangeTime Frame:
    3-10 days after start of therapy
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • To examine the difference between physician and patient perceptions of the symptoms of uUTI.
    date_rangeTime Frame:
    At baseline visit pre-therapy
    enhanced_encryption
    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.
    date_rangeTime Frame:
    1-3 days after end of therapy for efficacy and up to 30 days for safety
    enhanced_encryption
    Safety Issue:
    yes

Trial design

EXPRESS: Evaluating Cipro XR Patient Response, Education, Safety, and Satisfaction
Trial Type
Interventional
Intervention Type
Behavioral
Trial Purpose
Other
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2