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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00676533
First received: May 9, 2008
Last updated: October 10, 2013
Last verified: October 2013
  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.


Condition Intervention Phase
Urinary Tract Infection
Drug: Cipro XR (Ciprofloxacin, BAYQ3939)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cipro® XR Excellence in Therapeutic Response and Activity (eXtRa) - Assessing Symptom Relief in Urinary Tract Infections

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Activity Impairment Assessment (AIA) questionnaire [ Time Frame: TOC (+5 to +9 day post-treatment) ] [ Designated as safety issue: Yes ]
  • Clinical and bacteriological success rates [ Time Frame: TOC (+5 to +9 day post-treatment) ] [ Designated as safety issue: Yes ]
  • Incidence rates of adverse events [ Time Frame: TOC (+5 to +9 day post-treatment) ] [ Designated as safety issue: Yes ]

Enrollment: 276
Study Start Date: June 2003
Study Completion Date: January 2004
Arms Assigned Interventions
Experimental: Arm 1 Drug: Cipro XR (Ciprofloxacin, BAYQ3939)
3 tablets of Cipro XR 500 mg and were instructed to take 1 tablet per day for 3 days.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  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: NCT00676533

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35205
Huntsville, Alabama, United States, 35801
Montgomery, Alabama, United States, 36106
Tallassee, Alabama, United States, 36078
United States, Arizona
Chandler, Arizona, United States, 85225-2909
Mesa, Arizona, United States, 85201
Phoenix, Arizona, United States, 85014
Tempe, Arizona, United States, 85282
United States, California
Fresno, California, United States, 93710
Mission Hills, California, United States, 91345
San Diego, California, United States, 92128
San Diego, California, United States, 92182-4701
San Diego, California, United States, 92117
Yorba Linda, California, United States, 92886
United States, Connecticut
Avon, Connecticut, United States, 06001
United States, 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
United States, Georgia
Atlanta, Georgia, United States, 30308
Atlanta, Georgia, United States, 30342
Conyers, Georgia, United States, 30094
Fayetteville, Georgia, United States, 30214
United States, Idaho
Hayden, Idaho, United States, 83835
United States, Indiana
Evansville, Indiana, United States, 47713
United States, Maryland
Baltimore, Maryland, United States, 21210
Millersville, Maryland, United States, 21108-1571
United States, Michigan
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Elizabeth, New Jersey, United States, 07202-3672
United States, New York
Camillus, New York, United States, 13031
United States, Oregon
Eugene, Oregon, United States, 97404
United States, Pennsylvania
Feasterville, Pennsylvania, United States, 19053
United States, South Carolina
Simpsonville, South Carolina, United States, 29681
United States, Texas
Lake Jackson, Texas, United States, 77566
United States, Utah
Salt Lake City, Utah, United States, 84109
Salt Lake City, Utah, United States, 84121
United States, Washington
Seattle, Washington, United States, 98105-5221
Spokane, Washington, United States, 99216
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00676533     History of Changes
Other Study ID Numbers: 100544
Study First Received: May 9, 2008
Last Updated: October 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Bayer:
Cipro
Urinary Tract Infection

Additional relevant MeSH terms:
Communicable Diseases
Infection
Urinary Tract Infections
Urologic Diseases
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 24, 2014