The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Urinary Tract Infection in Females
NCT ID: NCT02094703
Last Updated: 2014-03-24
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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UNKNOWN
PHASE4
126 participants
INTERVENTIONAL
2013-04-30
2014-12-31
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
QUADRUPLE
Study Groups
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levofloxacin and solifenacin succinate
Levofloxacin 500 mg tablet and solifenacin succinate 5 mg tablet by mouth once daily for 3 days
Levofloxacin
Solifenacin succinate
levofloxacin and placebo
Levofloxacin 500 mg tablet and placebo (for solifenacin succinate) by mouth once daily for 3 days
Levofloxacin
Placebo (for Solifenacin succinate)
Interventions
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Levofloxacin
Solifenacin succinate
Placebo (for Solifenacin succinate)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* dysuria in symptomatic non complicated urinary tract infection
Exclusion Criteria
* geriatric Patients (\> 65 years old)
* pregnant Patients
* Patients with complicated urinary tract infection
* sexually transmitted infections
* Patients with pathological abnormalities in the urinary bladder, including stone/mass
* Catheter-mounted
* Neurological diseases/disorders
* patients with allergy/hypersensitivity with Levofloxacin/Solifenacin
18 Years
65 Years
FEMALE
No
Sponsors
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Astellas Pharma Indonesia Inc.
INDUSTRY
Pharos Life Corporation
INDUSTRY
Dr Cipto Mangunkusumo General Hospital
OTHER
Responsible Party
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Harrina Erlianti Rahardjo,MD,PhD
MD, PhD
Locations
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Cipto Mangunkusumo Hospital
Jakarta, Jakarta Special Capital Region, Indonesia
Countries
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Facility Contacts
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Other Identifiers
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URO-SOL-01-2012
Identifier Type: -
Identifier Source: org_study_id
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