A Phase IV Study of Cipro XR in Uncomplicated UTI

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.

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cipro XR (Ciprofloxacin, BAYQ3939)

Behavioral

Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days and brochure about UTI

Primary outcomes

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

Secondary outcomes

To examine the difference between physician and patient perceptions of the symptoms of uUTI.

Time frame: 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.

Time frame: 1-3 days after end of therapy for efficacy and up to 30 days for safety

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: EXPRESS

Important dates

Study start: 2003
Study completion: 2003
First posted: Apr 22, 2008
Registry last updated: Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed