check_circleStudy Completed
Urinary Tract Infections
Bayer Identifier:
11490
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study To Evaluate The Efficacy And Safety Of Ciprofloxacin Extended-Release (Cipro® XR) 1000 mg Tablets Given Once Daily For 7 To 14 Days In The Treatment Of Patients 18 Years Or Older With Complicated Urinary Tract Infections Caused By Pseudomonas Aeruginosa And Other Common Uropathogens
Trial purpose
Researchers want to find out if a drug called Cipro® XR (ciprofloxacin extended-release) can help people with a complicated urinary tract infection caused by a kind of bacteria called Pseudomonas aeruginosa. The study doctor will give Cipro XR to some people to see if it is safe and works to treat complicated urinary tract infections caused by Pseudomonas aeruginosa. The study doctor will also gather information about using Cipro XR to treat complicated urinary tract infections caused by other bacteria. About 500 people with complicated urinary tract infections who are 18 years old and older will join this study. Cipro XR is approved by the U.S. Food and Drug Administration (FDA) for the treatment of complicated urinary tract infections and acute uncomplicated pyelonephritis (inflammation of the kidney). The dose of Cipro XR used in this study (1000 mg a day for 7 to 14 days), has been shown to be safe and effective. This study is being done to gather more information on using this dose of Cipro XR for complicated urinary tract infections caused by Pseudomonas aeruginosa, as well as by other bacteria.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
500Trial Dates
May 2004 - September 2005Phase
Phase 4Could I Receive a placebo
NoProducts
Cipro XR (Ciprofloxacin, BAYQ3939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Center for Urological Research | La Mesa, 91942-3058, United States |
Completed | Urological Physicians of San Diego | San Diego, 92103, United States |
Completed | ACT - Albuquerque Clinical Trials | Albuquerque, 87102, United States |
Completed | Florida Foundation for Healthcare Research | Ocala, 34474, United States |
Completed | Madigan Army Medical Center | Tacoma, 98431-5000, United States |
Completed | Urology Group of New Mexico | Albuquerque, 87109, United States |
Completed | Alabama Research Center, LLC | Birmingham, 35209, United States |
Completed | Scottsdale Urologic & Reproductive Specialists | Scottsdale, 85258, United States |
Completed | South Florida Urology Center | Pembroke Pines, 33027, United States |
Completed | Clinical Research Solutions | Las Vegas, 89109, United States |
Completed | Rx for Life, Inc. | Cudahy, 90201, United States |
Completed | Iowa Clinic,PC/ Iowa Urololgy | Des Moines, 50309, United States |
Completed | Urology Specialists, PC | Waterbury, 06708, United States |
Completed | DiGiovanna Family Care Center | North Massapequa, 11758, United States |
Completed | VA New Jersey Health Care System | East Orange, 07918, United States |
Completed | Atlantic Urology Medical Group | Long Beach, 90806, United States |
Completed | South Coast Urological Medical Group | Laguna Hills, 92653, United States |
Completed | Urology San Antonio Research, PA | San Antonio, 78229, United States |
Completed | Urology of Indiana, LLC | Indianapolis, 46202, United States |
Completed | Nevada Urology Associates | Reno, 89511-2069, United States |
Completed | Medical Affiliated Research Center, Inc. | Huntsville, 35801, United States |
Completed | Urology Associates of Central California | Fresno, 93720-0153, United States |
Completed | Parkway Medical Center | Birmingham, 35206, United States |
Completed | Wyoming Research Foundation, Inc. | Cheyenne, 82001, United States |
Completed | Seton Health System | Troy, 12180-1695, United States |
Completed | VA Medical Center-Jefferson Barracks Division | St. Louis, 63125, United States |
Completed | Southeast Urology Network | Memphis, 38119, United States |
Completed | McGuire Veterans Affairs Medical Center | Richmond, 23249-0002, United States |
Completed | Health Care Partners Medical Group | Torrance, 90503, United States |
Completed | Bay State Clinical Trials, Inc | Watertown, 02472, United States |
Completed | Thomas Jefferson University Hospitals | Philadelphia, 19107-5096, United States |
Completed | Healthcare Partners Medical Group | Los Angeles, 90015, United States |
Completed | Oregon Urology Specialists | Eugene, 97401, United States |
Completed | University of Iowa Hospitals & Clinics | Iowa City, 52242-1089, United States |
Completed | Urology Associates, PC | Manhasset, 11030-1961, United States |
Primary Outcome
- To evaluate safety and efficacy of ciprofloxacin XR for treatment of subjects with complicated urinary tract infections caused by P. aeruginosa and other urinary pathogens.date_rangeTime Frame:28-42 days after therapyenhanced_encryptionyesSafety Issue:
Secondary Outcome
- Clinical responsedate_rangeTime Frame:TOC visitenhanced_encryptionyesSafety Issue:
- Clinical response post- treatmentdate_rangeTime Frame:28-42 days after therapyenhanced_encryptionyesSafety Issue:
- Adverse Event collectiondate_rangeTime Frame:Until end of studyenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
N/A