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

Urinary Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02094703
• Other study ID #: URO-SOL-01-2012
• Status: Recruiting
• Phase: Phase 4
• First received: March 10, 2014
• Last updated: March 19, 2014
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2014
• Source: Dr Cipto Mangunkusumo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Departement Kesehatan (Ministry of Health)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Levofloxacin

• Solifenacin succinate

• Placebo (for Solifenacin succinate)

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta

Sponsors (3)

Lead Sponsor	Collaborator
Dr Cipto Mangunkusumo General Hospital	Astellas Pharma Indonesia Inc., Pharos Life Corporation

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with storage symptoms		up to three days	No