Trial Condition(s):

Urinary Tract Infection

Cipro® XR in Therapeutic Response and Activity (eXtRa) - Assessing Symptom Relief in Urinary Tract Infections

Bayer Identifier:

100544

ClinicalTrials.gov Identifier:

NCT00676533

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
276
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Cipro XR (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Hillcrest Clinical Research, LLC

Simpsonville, United States, 29681

Status
Completed
 
Locations

Central Phoenix Medical Clinic, LLC

Phoenix, United States, 85014

Status
Completed
 
Locations

ProHealth Physicians, Inc.

Avon, United States, 06001

Status
Terminated
 
Locations

Clinical Research Advantage, Inc.

Mesa, United States, 85201

Status
Completed
 
Locations

Radiant Research - Gainesville

Gainesville, United States, 32605

Status
Completed
 
Locations

Tempe Primary Care Associates, PC

Tempe, United States, 85282

Status
Completed
 
Locations

Atlanta Center for Medical Research

Atlanta, United States, 30308

Status
Completed
 
Locations

Hayden Lake Family Physicians

Hayden, United States, 83835

Status
Completed
 
Locations

Facey Medical Research

Mission Hills, United States, 91345

Status
Completed
 
Locations

Star_W Research Center

Chandler, United States, 85225-2909

Status
Completed
 
Locations

Chiefland Medical Center

Chiefland, United States, 32626

Status
Completed
 
Locations

Drug Research & Analysis Corp.

Montgomery, United States, 36106

Status
Completed
 
Locations

R/D Clinical Research, Inc.

Lake Jackson, United States, 77566

Status
Completed
 
Locations

J. Lewis Research, Inc.

Salt Lake City, United States, 84109

Status
Completed
 
Locations

Feasterville Family Health Care Center

Feasterville, United States, 19053

Status
Completed
 
Locations

Jacksonville Center for Clinical Research

Jacksonville, United States, 32216

Status
Completed
 
Locations

Huntsville Clinic Family Practice

Huntsville, United States, 35801

Status
Completed
 
Locations

Office of Dr. Thomas A. Hooton, MD

Seattle, United States, 98105-5221

Status
Terminated
 
Locations

Florida Foundation for Healthcare Research

Ocala, United States, 34474

Status
Completed
 
Locations

Sierra Medical Research

Fresno, United States, 93710

Status
Terminated
 
Locations

Scripps Clinic

San Diego, United States, 92128

Status
Completed
 
Locations

University of Michigan

Ann Arbor, United States, 48109

Status
Terminated
 
Locations

Clinical Research Center of California

San Diego, United States, 92117

Status
Completed
 
Locations

Univ. of Maryland School of Medicine

Baltimore, United States, 21210

Status
Terminated
 
Locations

Radiant Research

West Palm Beach, United States, 33407

Status
Completed
 
Locations

Family Medicine Associates, PA at Shipley's Choice

Millersville, United States, 21108-1571

Status
Terminated
 
Locations

Insignia Care for Women, P.A.

Tampa, United States, 33607

Status
Completed
 
Locations

Office of Dr. Howard S. Ellison, MD

Conyers, United States, 30094

Status
Completed
 
Locations

River Road Medical Group

Eugene, United States, 97404

Status
Completed
 
Locations

Executive Health & Research Associates

Atlanta, United States, 30342

Status
Terminated
 
Locations

Capstone Clinical Trials, Inc.

Birmingham, United States, 35205

Status
Completed
 
Locations

St. Jude Heritage Medical Group

Yorba Linda, United States, 92886

Status
Completed
 
Locations

Southern Drug Research Network

Tallassee, United States, 36078

Status
Terminated
 
Locations

Welborn Clinic

Evansville, United States, 47713

Status
Terminated
 
Locations

Office of Dr. William Gray, MD

Spokane, United States, 99216

Status
Terminated
 
Locations

J. Lewis Research, Inc.

Salt Lake City, United States, 84121

Status
Completed
 
Locations

San Diego State University

San Diego, United States, 92182-4701

Status
Completed
 
Locations

Family Care Medical Group

Camillus, United States, 13031

Status
Completed
 
Locations

Central Jersey Health Care Associates, LLC

Elizabeth, United States, 07202-3672

Status
Terminated
 
Locations

Fayette Medical Clinic

Fayetteville, United States, 30214

Status
Terminated
 

Trial Design