A Phase IV Study of Cipro XR in Uncomplicated UTI (EXPRESS)
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00663806
First received: April 17, 2008
Last updated: June 16, 2009
Last verified: June 2009
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Urinary Tract Infections |
Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | EXPRESS: Evaluating Cipro XR Patient Response, Education, Safety, and Satisfaction |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 7614 |
| Study Start Date: | February 2003 |
| Study Completion Date: | July 2003 |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders 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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Affairs Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00663806 History of Changes |
| Other Study ID Numbers: | 100534 |
| Study First Received: | April 17, 2008 |
| Last Updated: | June 16, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Bayer:
|
UTI |
Additional relevant MeSH terms:
|
Urinary Tract Infections Infection Urologic Diseases Ciprofloxacin Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013