Comparison of Efficacy and Safety Between Imidafenacin and Fesoterodine in Patients With Overactive Bladder

Phase 4

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Imidafenacin; Drug: Fesoterodine

• Registration Number: NCT01578304
• Lead Sponsor: LG Life Sciences

Brief Summary

To evaluate the efficacy and safety after 12 weeks oral administration of Imidafenacin 0.1mg b.i.d versus Fesoterodine 4mg once daily for the urge incontinence and/or increased urinary frequency associated with urgency as may occur in patients with overactive bladder.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-04
• Study First Submitted: 2012-04-12
• Study First Submitted QC: 2012-04-13
• Last Update Submitted: 2012-04-13
• Study First Posted: 2012-04-16
• Last Update Posted: 2012-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

• Male and female patients with overactive bladder aged 20 years or more
• subject who had the continuos symptom for 3 months or more
• subject prepare a symptom diary and was deemed eligible for the study by the investigator
• 8 times or more of daily mean urination frequency
• 2 times or more of daily mean frequency of a sense of urinary urgency or 2 times or more of urge incontinence frequency

Exclusion Criteria

• subjects with clinically significant stress urge incontinence, patients with urinary tract infections or relapsing urinary tract infections who had received treatment more than 4 times in the previous year
• subjects with diseases prohibiting anti-cholinergics from administration
• subjects who used an indwelling catheter or intermittent self intubation program, patients who had prostatic hyperplasia, prostatic cancer, bladder cancer,bladder stones, interstitial cystitis as complications
• subjects who received lower urinary tract surgery within 6 months
• subjects with a catheter placed or intermittent catheterization
• subjects who were deemed ineligible for the study by the investigator or sub-investigator, pregnant women, nursing women, and women who are planning pregnancy or have not used proper contraceptives during the study period
• subjects who are within 1 month after other clinical study was completed
• subjects having 100mL or more of residual urine
• subjects who had acute urinary retention history
• subjects who have been administered Prohibited concomitant medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imidafenacin	Imidafenacin	-
Fesoterodine	Fesoterodine	-

Primary Outcome Measures

Name	Time	Method
Difference in daily mean urination frequency between the end of treatment period(Week 12) and the end of observation period(Baseline, Week 0)	up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Difference in daily mean Urinary incontinence frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)	up to 12 weeks
Difference in daily mean urge incontinence frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)	up to 12 weeks
Difference in daily mean nocturia frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)	up to 12 weeks
Difference in daily mean urination frequency between each evaluation time(treatment period Week 4, Week 8) and the end of observation period(baselien, week 0)	up to 12 weeks
Difference in QoL score between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)	up to 12 weeks
Adverse events	up to 24 weeks
laboratory test	up to 12 weeks
vital signs	up to 12 weeks
residual urine	up to 12 weeks

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of