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

NCT ID: NCT00676533

Last Updated: 2013-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2004-01-31

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.

Conditions

Urinary Tract Infection

Keywords

Cipro; Urinary Tract Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Cipro XR (Ciprofloxacin, BAYQ3939)

Intervention Type: DRUG

3 tablets of Cipro XR 500 mg and were instructed to take 1 tablet per day for 3 days.

Interventions

Cipro XR (Ciprofloxacin, BAYQ3939)

3 tablets of Cipro XR 500 mg and were instructed to take 1 tablet per day for 3 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Birmingham, Alabama, United States

Huntsville, Alabama, United States

Montgomery, Alabama, United States

Tallassee, Alabama, United States

Chandler, Arizona, United States

Mesa, Arizona, United States

Phoenix, Arizona, United States

Tempe, Arizona, United States

Fresno, California, United States

Mission Hills, California, United States

San Diego, California, United States

San Diego, California, United States

San Diego, California, United States

Yorba Linda, California, United States

Avon, Connecticut, United States

Chiefland, Florida, United States

Gainesville, Florida, United States

Jacksonville, Florida, United States

Ocala, Florida, United States

Tampa, Florida, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Atlanta, Georgia, United States

Conyers, Georgia, United States

Fayetteville, Georgia, United States

Hayden, Idaho, United States

Evansville, Indiana, United States

Baltimore, Maryland, United States

Millersville, Maryland, United States

Ann Arbor, Michigan, United States

Elizabeth, New Jersey, United States

Camillus, New York, United States

Eugene, Oregon, United States

Feasterville, Pennsylvania, United States

Simpsonville, South Carolina, United States

Lake Jackson, Texas, United States

Salt Lake City, Utah, United States

Salt Lake City, Utah, United States

Seattle, Washington, United States

Spokane, Washington, United States

Countries

United States

Other Identifiers

100544

Identifier Type: -

Identifier Source: org_study_id