A Phase IV Study of Cipro XR in Uncomplicated UTI - Tabular View

Tracking Information

First Received Date ^ICMJE

April 17, 2008

Last Updated Date

June 16, 2009

Start Date ^ICMJE

February 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: 3-10 days after start of therapy ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00663806 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To examine the difference between physician and patient perceptions of the symptoms of uUTI. [ Time Frame: At baseline visit pre-therapy ] [ Designated as 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. [ Time Frame: 1-3 days after end of therapy for efficacy and up to 30 days for safety ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Phase IV Study of Cipro XR in Uncomplicated UTI

Official Title ^ICMJE

EXPRESS: Evaluating Cipro XR Patient Response, Education, Safety, and Satisfaction

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Urinary Tract Infections

Intervention ^ICMJE

Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

7614

Completion Date

July 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00663806

Responsible Party

Medical Affairs Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.

Study ID Numbers ^ICMJE

100534

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP