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

NCT02094703 | Unknown Phase 4

• 1 other identifier: URO-SOL-01-2012
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infection

Keywords

female; age 18-65 years; storage symptoms; clinical urinary tract infection; non complicated

Outcome Measures

Primary Outcomes (1)

• Number of participants with storage symptoms

  up to three days

Study Arms (2)

levofloxacin and solifenacin succinate

EXPERIMENTAL

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

Drug: Levofloxacin; Drug: Solifenacin succinate

levofloxacin and placebo

ACTIVE COMPARATOR

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

Drug: Levofloxacin; Drug: Placebo (for Solifenacin succinate)

Interventions

Levofloxacin DRUG

Also known as: neslav

levofloxacin and placebo; levofloxacin and solifenacin succinate

Solifenacin succinate DRUG

levofloxacin and solifenacin succinate

Placebo (for Solifenacin succinate) DRUG

levofloxacin and placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Levofloxacin; Solifenacin Succinate

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Tetrahydroisoquinolines; Isoquinolines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 24, 2014
• Study Start: April 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 24, 2014

Record last verified: 2014-03

Locations

ID (1)