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

Primary Purpose

Urinary Tract Infection

Status
Unknown status
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
Levofloxacin
Solifenacin succinate
Placebo (for Solifenacin succinate)
Sponsored by
Dr Cipto Mangunkusumo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infection focused on measuring female, age 18-65 years, storage symptoms, clinical urinary tract infection, non complicated

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cipto Mangunkusumo HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

levofloxacin and solifenacin succinate

levofloxacin and placebo

Arm Description

Levofloxacin 500 mg tablet and solifenacin succinate 5 mg tablet by mouth once daily for 3 days

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

Outcomes

Primary Outcome Measures

Number of participants with storage symptoms

Secondary Outcome Measures

Full Information

First Posted
March 10, 2014
Last Updated
March 19, 2014
Sponsor
Dr Cipto Mangunkusumo General Hospital
Collaborators
Astellas Pharma Indonesia Inc., Pharos Life Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02094703
Brief Title
The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Urinary Tract Infection in Females
Official Title
The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Symptomatic Non-complicated Urinary Tract Infection in Females
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr Cipto Mangunkusumo General Hospital
Collaborators
Astellas Pharma Indonesia Inc., Pharos Life Corporation

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
female, age 18-65 years, storage symptoms, clinical urinary tract infection, non complicated

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
levofloxacin and solifenacin succinate
Arm Type
Experimental
Arm Description
Levofloxacin 500 mg tablet and solifenacin succinate 5 mg tablet by mouth once daily for 3 days
Arm Title
levofloxacin and placebo
Arm Type
Active Comparator
Arm Description
Levofloxacin 500 mg tablet and placebo (for solifenacin succinate) by mouth once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Other Intervention Name(s)
neslav
Intervention Type
Drug
Intervention Name(s)
Solifenacin succinate
Intervention Type
Drug
Intervention Name(s)
Placebo (for Solifenacin succinate)
Primary Outcome Measure Information:
Title
Number of participants with storage symptoms
Time Frame
up to three days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cipto Mangunkusumo Hospital
City
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harrina Erlianti Rahardjo
Phone
+62 816-825-226
Email
harrinaerlianti@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

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