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

Condition(s) targeted: Urinary Tract Infection

Intervention: Cipro XR (Ciprofloxacin, BAYQ3939) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary outcome: 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

Secondary outcome:

Activity Impairment Assessment (AIA) questionnaire

Clinical and bacteriological success rates

Incidence rates of adverse events

Minimum age: 18 Years. Maximum age: 78 Years. Gender(s): Female.

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 - 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. 3C or >/= 101F, 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

Huntsville, Alabama 35801, United States

Montgomery, Alabama 36106, United States

Birmingham, Alabama 35205, United States

Phoenix, Arizona 85014, United States

Mesa, Arizona 85201, United States

Tempe, Arizona 85282, United States

Chandler, Arizona 85225-2909, United States

San Diego, California 92128, United States

San Diego, California 92103, United States

Mission Hills, California 91345, United States

San Diego, California 92182-4701, United States

Yorba Linda, California 92886, United States

Jacksonville, Florida 32216, United States

Ocala, Florida 34474, United States

Gainesville, Florida 32605, United States

West Palm Beach, Florida 33407, United States

Tampa, Florida 33607, United States

Chiefland, Florida 32626, United States

Atlanta, Georgia 30308, United States

Conyers, Georgia 30094, United States

Hayden, Idaho 83835, United States

Camillus, New York 13031, United States

Eugene, Oregon 97404, United States

Feasterville, Pennsylvania 19053, United States

Simpsonville, South Carolina 29681, United States

Lake Jackson, Texas 77566, United States

Salt Lake City, Utah 84121, United States

Salt Lake City, Utah 84109, United States

#PL#Curr. Med. Res. Opin. 21 (8) 1241- 1250 (2005) , ISSN:0300-7995

#PL#PubMed.

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Starting date: June 2003
Ending date: January 2004
Last updated: May 12, 2008