- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00676533
Cipro® XR in Therapeutic Response and Activity (eXtRa) - Assessing Symptom Relief in Urinary Tract Infections
October 10, 2013 updated by: Bayer
Cipro® XR Excellence in Therapeutic Response and Activity (eXtRa) - Assessing Symptom Relief in Urinary Tract Infections
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
276
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35205
-
Huntsville, Alabama, United States, 35801
-
Montgomery, Alabama, United States, 36106
-
Tallassee, Alabama, United States, 36078
-
-
Arizona
-
Chandler, Arizona, United States, 85225-2909
-
Mesa, Arizona, United States, 85201
-
Phoenix, Arizona, United States, 85014
-
Tempe, Arizona, United States, 85282
-
-
California
-
Fresno, California, United States, 93710
-
Mission Hills, California, United States, 91345
-
San Diego, California, United States, 92128
-
San Diego, California, United States, 92117
-
San Diego, California, United States, 92182-4701
-
Yorba Linda, California, United States, 92886
-
-
Connecticut
-
Avon, Connecticut, United States, 06001
-
-
Florida
-
Chiefland, Florida, United States, 32626
-
Gainesville, Florida, United States, 32605
-
Jacksonville, Florida, United States, 32216
-
Ocala, Florida, United States, 34474
-
Tampa, Florida, United States, 33607
-
West Palm Beach, Florida, United States, 33407
-
-
Georgia
-
Atlanta, Georgia, United States, 30342
-
Atlanta, Georgia, United States, 30308
-
Conyers, Georgia, United States, 30094
-
Fayetteville, Georgia, United States, 30214
-
-
Idaho
-
Hayden, Idaho, United States, 83835
-
-
Indiana
-
Evansville, Indiana, United States, 47713
-
-
Maryland
-
Baltimore, Maryland, United States, 21210
-
Millersville, Maryland, United States, 21108-1571
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
-
-
New Jersey
-
Elizabeth, New Jersey, United States, 07202-3672
-
-
New York
-
Camillus, New York, United States, 13031
-
-
Oregon
-
Eugene, Oregon, United States, 97404
-
-
Pennsylvania
-
Feasterville, Pennsylvania, United States, 19053
-
-
South Carolina
-
Simpsonville, South Carolina, United States, 29681
-
-
Texas
-
Lake Jackson, Texas, United States, 77566
-
-
Utah
-
Salt Lake City, Utah, United States, 84121
-
Salt Lake City, Utah, United States, 84109
-
-
Washington
-
Seattle, Washington, United States, 98105-5221
-
Spokane, Washington, United States, 99216
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:- Non-pregnant, non-lactating women between the ages of 18 and 65 years with signs and symptoms of acute, uncomplicated, symptomatic lower UTI were eligible for enrolment.
Dysuria and at least 1 clinical sign or symptom of a lower UTI (frequency, urgency, suprapubic pain, or gross hematuria) had to be present, with symptom onset </= 72 hours before study entry.
- In addition, 1 pretreatment clean-catch MSU culture had to be positive for 1 to 2 urinary pathogens (>/= 10.000 colony-forming units {CFU}/mL).
Women of childbearing potential were required to use 2 reliable methods of contraception during exposure to study drug.
Exclusion Criteria:- Men- Women who were pregnant, nursing, or not using 2 medically accepted, effective methods of birth control- Known or suspected hypersensitivity to ciprofloxacin or the quinolone class of antimicrobials- Subjects taking urinary analgesic medication (phenazopyridine-containing products {eg, Pyridium}) within 24 hours before first dose of study drug and throughout the study for urinary tract pain- Subjects taking other analgesic medications (eg, nonsteroidal anti-inflammatory drugs [NSAID], acetaminophen-containing products, etc) for urinary tract pain or any other pain (eg, headache, back pain, joint pain, dental pain, sore muscles, etc) within 2 dosing intervals for that medication before first dose of study drug and throughout the study.
More specifically, a subject who had taken a medication for pain could not be entered into the study until the time elapsed since her last dose of the medication was equal to at least 2 dosing intervals for that medication.-
History of gastrointestinal illness that could interfere with absorption of orally administered antimicrobials- Subjects requiring concomitant administration of multivalent cation-containing products such as magnesium/aluminum antacids, sucralfate, Videx (didanosine) chewable/buffered tablets or pediatric powder, or products containing calcium, iron, or zinc, such as multivitamin preparations.
These medications were not to be taken less than 6 hours before or 2 hours after study drug administration.
- Subjects experiencing vaginitis- Subjects with a temperature >/= 38.3°C or >/= 101°F, flank pain, chills, or any other manifestations suggestive of upper UTI - Subjects with evidence of factors predisposing to the development of UTIs, including calculi, stricture, primary renal disease (eg, polycystic renal disease), or neurogenic bladder - Subjects currently taking, or who might require, antibiotics other than Cipro XR during the study period- Subjects who had received any systemic antibiotic therapy in the previous 48 hours, for any reason- Subjects who, in the opinion of the investigator, were unsuitable for enrollment and were unlikely to complete the course of treatment or to be available for follow-up- Subjects unable or unwilling to comply with the use of an electronic subject diary to record UTI symptoms and impairment of normal daily activities- Subjects requiring concomitant administration of theophylline - Inability to take oral medication for any reason - Subjects with >/= 3 episodes of UTIs in the past 12 months - Subjects with onset of symptoms more than 72 hours prior to study entry - Subjects with symptoms of a UTI within the 4 weeks prior to the present episode - Subjects with previous history of tendinopathy associated with fluoroquinolones - Subjects diagnosed with a rapidly fatal underlying disease (death expected within 6 months) - Subjects previously enrolled in this clinical study - Subjects with known neutrophil count < 1000/mm3, CD4 < 200/mm3, or other conditions associated with significant depression of host defense; HIV testing was not mandatory - Subjects taking an investigational drug in the last 30 days - Subjects who could not begin answering the first visit baseline questionnaire by 5:00 pm
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arm 1
|
3 tablets of Cipro XR 500 mg and were instructed to take 1 tablet per day for 3 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: TOC (+5 to +9 day post-treatment)
|
TOC (+5 to +9 day post-treatment)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Activity Impairment Assessment (AIA) questionnaire
Time Frame: TOC (+5 to +9 day post-treatment)
|
TOC (+5 to +9 day post-treatment)
|
Clinical and bacteriological success rates
Time Frame: TOC (+5 to +9 day post-treatment)
|
TOC (+5 to +9 day post-treatment)
|
Incidence rates of adverse events
Time Frame: TOC (+5 to +9 day post-treatment)
|
TOC (+5 to +9 day post-treatment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Study Completion (ACTUAL)
January 1, 2004
Study Registration Dates
First Submitted
May 9, 2008
First Submitted That Met QC Criteria
May 12, 2008
First Posted (ESTIMATE)
May 13, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
October 14, 2013
Last Update Submitted That Met QC Criteria
October 10, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Urologic Diseases
- Disease Attributes
- Infections
- Communicable Diseases
- Urinary Tract Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Ciprofloxacin
Other Study ID Numbers
- 100544
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urinary Tract Infection
-
Gloucestershire Hospitals NHS Foundation TrustUnknownCatheter Infection | Urinary Tract Infection in Pregnancy | Urinary Tract Infection Following Delivery
-
Lawson Health Research InstituteUniversity of Western Ontario, CanadaCompletedUrinary Tract Infection | Recurrent Urinary Tract InfectionCanada
-
National Center for Complementary and Integrative...Office of Dietary Supplements (ODS)UnknownUrinary Tract InfectionCanada
-
National Institute of Allergy and Infectious Diseases...TerminatedUrinary Tract InfectionUnited States
-
University Of PerugiaUnknownUrinary Tract Infection
-
NanovibronixShaare Zedek Medical CenterUnknownUrinary Tract InfectionIsrael
-
Hadassah Medical OrganizationUnknown
-
Impatients N.V. trading as myTomorrowsInmunotek S.L.No longer availableUrinary Tract Infections | Bladder Infection | Recurrent Urinary Tract Infection | Urinary Tract Infection Bacterial | Chronic Urinary Tract InfectionCzechia, Denmark, Serbia, France, Germany, Turkey, Belgium, Finland, Luxembourg, Netherlands, Norway, Romania, Slovakia, Slovenia, Sweden
-
Bactiguard ABRehab Station StockholmCompletedComplications; Catheter, Urinary Infection or InflammationSweden
-
University of ManitobaTerminatedComplicated Urinary InfectionCanada
Clinical Trials on Cipro XR (Ciprofloxacin, BAYQ3939)
-
BayerCompletedUrinary Tract InfectionItaly
-
BayerCompletedUrinary Tract InfectionsUnited States
-
BayerCompletedUrinary Tract Infections
-
BayerNovartisCompletedCystic FibrosisUnited States, Israel, Germany, Canada, Australia, Sweden, Denmark, Norway, United Kingdom
-
BayerCompletedPulmonary Disease, Chronic Obstructive | InfectionGermany
-
BayerCompleted
-
Dr. Reddy's Laboratories LimitedCompleted
-
BayerNovartisCompletedBronchiectasisSpain, Germany, Australia, United States, United Kingdom, Sweden
-
Dr. Reddy's Laboratories LimitedCompleted