Cipro® XR in Therapeutic Response and Activity (eXtRa) - Assessing Symptom Relief in Urinary Tract Infections
Cipro® XR Excellence in Therapeutic Response and Activity (eXtRa) - Assessing Symptom Relief in Urinary Tract Infections
1 other identifier
interventional
276
1 country
40
Brief Summary
The primary objective of this clinical trial was to determine the time to improvement of the signs and symptoms (eg, dysuria, frequency, urgency, gross hematuria, suprapubic pain, hesitancy, low back pain) of acute, uncomplicated, symptomatic, lower UTIs in women treated with Cipro XR 500 mg once daily for 3 days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2003
Shorter than P25 for phase_4
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 9, 2008
CompletedFirst Posted
Study publicly available on registry
May 13, 2008
CompletedOctober 14, 2013
October 1, 2013
May 9, 2008
October 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to improvement of the signs and symptoms (eg, dysuria, frequency, urgency, gross hematuria, suprapubic pain, hesitancy, low back pain) of acute, uncomplicated, symptomatic, lower UTIs
TOC (+5 to +9 day post-treatment)
Secondary Outcomes (3)
Activity Impairment Assessment (AIA) questionnaire
TOC (+5 to +9 day post-treatment)
Clinical and bacteriological success rates
TOC (+5 to +9 day post-treatment)
Incidence rates of adverse events
TOC (+5 to +9 day post-treatment)
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
3 tablets of Cipro XR 500 mg and were instructed to take 1 tablet per day for 3 days.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (40)
Unknown Facility
Birmingham, Alabama, 35205, United States
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Montgomery, Alabama, 36106, United States
Unknown Facility
Tallassee, Alabama, 36078, United States
Unknown Facility
Chandler, Arizona, 85225-2909, United States
Unknown Facility
Mesa, Arizona, 85201, United States
Unknown Facility
Phoenix, Arizona, 85014, United States
Unknown Facility
Tempe, Arizona, 85282, United States
Unknown Facility
Fresno, California, 93710, United States
Unknown Facility
Mission Hills, California, 91345, United States
Unknown Facility
San Diego, California, 92117, United States
Unknown Facility
San Diego, California, 92128, United States
Unknown Facility
San Diego, California, 92182-4701, United States
Unknown Facility
Yorba Linda, California, 92886, United States
Unknown Facility
Avon, Connecticut, 06001, United States
Unknown Facility
Chiefland, Florida, 32626, United States
Unknown Facility
Gainesville, Florida, 32605, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Ocala, Florida, 34474, United States
Unknown Facility
Tampa, Florida, 33607, United States
Unknown Facility
West Palm Beach, Florida, 33407, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Atlanta, Georgia, 30342, United States
Unknown Facility
Conyers, Georgia, 30094, United States
Unknown Facility
Fayetteville, Georgia, 30214, United States
Unknown Facility
Hayden, Idaho, 83835, United States
Unknown Facility
Evansville, Indiana, 47713, United States
Unknown Facility
Baltimore, Maryland, 21210, United States
Unknown Facility
Millersville, Maryland, 21108-1571, United States
Unknown Facility
Ann Arbor, Michigan, 48109, United States
Unknown Facility
Elizabeth, New Jersey, 07202-3672, United States
Unknown Facility
Camillus, New York, 13031, United States
Unknown Facility
Eugene, Oregon, 97404, United States
Unknown Facility
Feasterville, Pennsylvania, 19053, United States
Unknown Facility
Simpsonville, South Carolina, 29681, United States
Unknown Facility
Lake Jackson, Texas, 77566, United States
Unknown Facility
Salt Lake City, Utah, 84109, United States
Unknown Facility
Salt Lake City, Utah, 84121, United States
Unknown Facility
Seattle, Washington, 98105-5221, United States
Unknown Facility
Spokane, Washington, 99216, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2008
First Posted
May 13, 2008
Study Start
June 1, 2003
Study Completion
January 1, 2004
Last Updated
October 14, 2013
Record last verified: 2013-10