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

Phase IV Study to Evaluate the Efficacy and Safety Imidafenacin Versus Fesoterodine in Patients With Overactive Bladder

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Imidafenacin; Drug: Fesoterodine

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imidafenacin	Drug: Imidafenacin; Tablet, 12 weeks twice daily
Active Comparator: Fesoterodine	Drug: Fesoterodine; Tablet, 12 weeks once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: LG Life Sciences
• Collaborators: Kyorin Pharmaceutical Co.,Ltd
• Investigators: Principal Investigator: KYU-SUNG LEE, M.D., Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: April 12, 2012
• First Submitted That Met QC Criteria: April 13, 2012
• First Posted (Estimate): April 16, 2012

Study Record Updates

• Last Update Posted (Estimate): April 16, 2012
• Last Update Submitted That Met QC Criteria: April 13, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Overactive bladder
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Fesoterodine
• Other Study ID Numbers: LG-IFCL002