check_circleStudy Completed

Urinary Tract Infections

Bayer Identifier:

100534

ClinicalTrials.gov Identifier:

NCT00663806

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

Female

Age

18 - 65 Years
  • - 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.
  • - Pregnant or nursing
    - Complicated UTI
    - Allergy to Cipro XR

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

Additional Information

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