Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections
NCT ID: NCT00668122
Last Updated: 2009-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
212 participants
INTERVENTIONAL
2004-03-31
2006-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
Cipro XR (Ciprofloxacin, BAYQ3939)
Ciprofloxacin XR 1000 mg orally once a day
Arm 2
Cipro IR (Ciprofloxacin, BAYQ3939)
Ciprofloxacin IR 500 mg orally twice a day
Interventions
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Cipro XR (Ciprofloxacin, BAYQ3939)
Ciprofloxacin XR 1000 mg orally once a day
Cipro IR (Ciprofloxacin, BAYQ3939)
Ciprofloxacin IR 500 mg orally twice a day
Eligibility Criteria
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Inclusion Criteria
* One or more of the following underlying conditions suggestive of cUTI:
* Indwelling urinary catheter.
* 100 mL of residual urine after voiding.
* Neurogenic bladder.
* Obstructive uropathy due to lithiasis, tumor or fibrosis.
* Acute urinary retention in men.
Exclusion Criteria
* Have a history of allergy to quinolones
* Are unable to take oral medication
* Have an intractable infection requiring \> 14 days of therapy
* Have a requirement for concomitant administration of sucralfate or divalent and trivalent cations such as iron or antacids containing magnesium, aluminum or calcium
* Have prostatitis or epididymitis
* Have had a renal transplant
* Have ileal loop or vesica- urethral reflux
* Have significant liver or kidney impairment
* Have a history of tendinopathy associated with fluoroquinolones
* Are pregnant, nursing
* Have a history of convulsions or CNS disorders
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer HealthCare AG
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Monza, Milano, Italy
Camposampiero, Padova, Italy
Orbassano, Torino, Italy
Busto Arsizio, Varese, Italy
Bassano del Grappa, Vicenza, Italy
Alessandria, , Italy
Bari, , Italy
Benevento, , Italy
Bergamo, , Italy
Bologna, , Italy
Caserta, , Italy
Catania, , Italy
Chieti, , Italy
Florence, , Italy
Frosinone, , Italy
Genova, , Italy
Genova, , Italy
L’Aquila, , Italy
Mantova, , Italy
Massa Carrara, , Italy
Messina, , Italy
Milan, , Italy
Napoli, , Italy
Palermo, , Italy
Perugia, , Italy
Potenza, , Italy
Reggio Calabria, , Italy
Reggio Emilia, , Italy
Rimini, , Italy
Roma, , Italy
Roma, , Italy
Roma, , Italy
Sassari, , Italy
Syracuse, , Italy
Torino, , Italy
Trieste, , Italy
Varese, , Italy
Verona, , Italy
Countries
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Other Identifiers
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11454
Identifier Type: -
Identifier Source: org_study_id