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

March 19, 2014 updated by: Harrina Erlianti Rahardjo,MD,PhD, Dr Cipto Mangunkusumo General Hospital

The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Symptomatic Non-complicated Urinary Tract Infection in Females

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 10430
        • Recruiting
        • Cipto Mangunkusumo hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: levofloxacin and solifenacin succinate
Levofloxacin 500 mg tablet and solifenacin succinate 5 mg tablet by mouth once daily for 3 days
Drug: Levofloxacin
Other Names:
  • neslav
Drug: Solifenacin succinate
Active Comparator: levofloxacin and placebo
Levofloxacin 500 mg tablet and placebo (for solifenacin succinate) by mouth once daily for 3 days
Drug: Levofloxacin
Other Names:
  • neslav
Drug: Placebo (for Solifenacin succinate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with storage symptoms
Time Frame: up to three days
up to three days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Cipto Mangunkusumo General Hospital

Collaborators

Astellas Pharma Indonesia Inc.
Pharos Life Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

November 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

March 10, 2014

First Submitted That Met QC Criteria

March 19, 2014

First Posted (Estimate)

March 24, 2014

Study Record Updates

Last Update Posted (Estimate)

March 24, 2014

Last Update Submitted That Met QC Criteria

March 19, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URO-SOL-01-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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