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A Phase IV Study of Cipro XR in Uncomplicated UTI

NCT ID: NCT00663806

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

7614 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2003-07-31

Brief Summary

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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

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Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Cipro XR (Ciprofloxacin, BAYQ3939)

Intervention Type BEHAVIORAL

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

Arm 2

Group Type EXPERIMENTAL

Cipro XR (Ciprofloxacin, BAYQ3939)

Intervention Type BEHAVIORAL

Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days; not given brochure about UTI

Interventions

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Cipro XR (Ciprofloxacin, BAYQ3939)

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

Intervention Type BEHAVIORAL

Cipro XR (Ciprofloxacin, BAYQ3939)

Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days; not given brochure about UTI

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Other Identifiers

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100534

Identifier Type: -

Identifier Source: org_study_id