The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Urinary Tract Infection in Females

NCT ID: NCT02094703

Last Updated: 2014-03-24

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-12-31

Brief Summary

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The efficacy of Solifenacin Succinate 5 mg as adjuvant therapy and levofloxacin (500 mg) for short-term treatment to reduce symptoms in patients with symptomatic non complicated urinary tract infection in females.

Detailed Description

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Conditions

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Urinary Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Group Type EXPERIMENTAL

Levofloxacin

Intervention Type DRUG

Solifenacin succinate

Intervention Type DRUG

levofloxacin and placebo

Levofloxacin 500 mg tablet and placebo (for solifenacin succinate) by mouth once daily for 3 days

Group Type ACTIVE_COMPARATOR

Levofloxacin

Intervention Type DRUG

Placebo (for Solifenacin succinate)

Intervention Type DRUG

Interventions

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Levofloxacin

Intervention Type DRUG

Solifenacin succinate

Intervention Type DRUG

Placebo (for Solifenacin succinate)

Intervention Type DRUG

Other Intervention Names

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neslav

Eligibility Criteria

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Inclusion Criteria

* females (18-65 years old)
* dysuria in symptomatic non complicated urinary tract infection

Exclusion Criteria

* Pediatric Patients (\< 18 years old)
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Indonesia Inc.

INDUSTRY

Sponsor Role collaborator

Pharos Life Corporation

INDUSTRY

Sponsor Role collaborator

Dr Cipto Mangunkusumo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Harrina Erlianti Rahardjo,MD,PhD

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cipto Mangunkusumo Hospital

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Facility Contacts

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Harrina Erlianti Rahardjo

Role: primary

+62 816-825-226

Other Identifiers

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URO-SOL-01-2012

Identifier Type: -

Identifier Source: org_study_id

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