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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00663806
First received: April 17, 2008
Last updated: October 10, 2013
Last verified: October 2013
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663806

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00663806     History of Changes
Other Study ID Numbers: 100534
Study First Received: April 17, 2008
Last Updated: October 10, 2013
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 July 22, 2014