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

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ClinicalTrials.gov Identifier: NCT02094703
Recruitment Status : Unknown
Verified March 2014 by Harrina Erlianti Rahardjo,MD,PhD, Dr Cipto Mangunkusumo General Hospital.
Recruitment status was:  Recruiting
First Posted : March 24, 2014
Last Update Posted : March 24, 2014
Sponsor:
Collaborators:
Astellas Pharma Indonesia Inc.
Pharos Life Corporation
Information provided by (Responsible Party):
Harrina Erlianti Rahardjo,MD,PhD, Dr Cipto Mangunkusumo General Hospital

Study Description
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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
Urinary Tract Infection Drug: Levofloxacin Drug: Solifenacin succinate Drug: Placebo (for Solifenacin succinate) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : December 2014

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Arms and Interventions
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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 Name: 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 Name: neslav

Drug: Placebo (for Solifenacin succinate)


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with storage symptoms [ Time Frame: up to three days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02094703


Locations
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Indonesia
Cipto Mangunkusumo Hospital Recruiting
Jakarta, Indonesia, 10430
Contact: Harrina Erlianti Rahardjo    +62 816-825-226    harrinaerlianti@yahoo.com   
Sponsors and Collaborators
Dr Cipto Mangunkusumo General Hospital
Astellas Pharma Indonesia Inc.
Pharos Life Corporation
More Information
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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: March 24, 2014    Key Record Dates
Last Update Posted: March 24, 2014
Last Verified: March 2014
Keywords provided by Harrina Erlianti Rahardjo,MD,PhD, Dr Cipto Mangunkusumo General Hospital:
female
age 18-65 years
storage symptoms
clinical urinary tract infection
non complicated
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Levofloxacin
Ofloxacin
Solifenacin Succinate
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
 Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Urological Agents