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

Sponsor
Dr Cipto Mangunkusumo General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02094703
Collaborator
Astellas Pharma Indonesia Inc. (Industry), Pharos Life Corporation (Industry)
126
Enrollment
1
Location
2
Arms
20
Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Levofloxacin
  • Drug: Solifenacin succinate
  • Drug: Placebo (for Solifenacin succinate)
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Symptomatic Non-complicated Urinary Tract Infection in Females
Study Start Date :
Apr 1, 2013
Anticipated Primary Completion Date :
Nov 1, 2014
Anticipated Study Completion Date :
Dec 1, 2014

Arms and Interventions

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)

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with storage symptoms [up to three days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cipto Mangunkusumo Hospital Jakarta Indonesia 10430

    Sponsors and Collaborators

    • Dr Cipto Mangunkusumo General Hospital
    • Astellas Pharma Indonesia Inc.
    • Pharos Life Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Harrina Erlianti Rahardjo,MD,PhD, MD, PhD, Dr Cipto Mangunkusumo General Hospital
    ClinicalTrials.gov Identifier:
    NCT02094703
    Other Study ID Numbers:
    • URO-SOL-01-2012
    First Posted:
    Mar 24, 2014
    Last Update Posted:
    Mar 24, 2014
    Last Verified:
    Mar 1, 2014
    Keywords provided by Harrina Erlianti Rahardjo,MD,PhD, MD, PhD, Dr Cipto Mangunkusumo General Hospital
    female
    age 18-65 years
    storage symptoms
    clinical urinary tract infection
    non complicated
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Urinary Tract Infections
    Levofloxacin
    Ofloxacin
    Solifenacin Succinate

    Study Results

    No Results Posted as of Mar 24, 2014