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A Phase IV Study of Cipro XR in Uncomplicated UTI (EXPRESS)

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ClinicalTrials.gov Identifier: NCT00663806
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7614 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: EXPRESS: Evaluating Cipro XR Patient Response, Education, Safety, and Satisfaction
Study Start Date : February 2003
Actual Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939)
Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days and brochure about UTI
Experimental: Arm 2 Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939)
Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days; not given brochure about UTI



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. To examine the difference between physician and patient perceptions of the symptoms of uUTI. [ Time Frame: At baseline visit pre-therapy ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663806


Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00663806     History of Changes
Other Study ID Numbers: 100534
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by Bayer:
UTI

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors