Clinical trial NCT01578304: Comparison of Efficacy and Safety Between Imidafenacin and Fesoterodine in Patients With Overactive Bladder
Official title: Phase IV Study to Evaluate the Efficacy and Safety Imidafenacin Versus Fesoterodine in Patients With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Keywords: Overactive bladder
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
Collaborators: name: Kyorin Pharmaceutical Co.,Ltd
First posted: 2012-04-16
Enrollment: 207
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in daily mean urination frequency between the end of treatment period(Week 12) and the end of observation period(Baseline, Week 0)
timeFrame: up to 12 weeks
Secondary outcomes:
measure: 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)
timeFrame: up to 12 weeks
measure: 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)
timeFrame: up to 12 weeks
measure: 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)
timeFrame: up to 12 weeks
measure: 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)
timeFrame: up to 12 weeks
measure: 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)
timeFrame: up to 12 weeks
measure: Adverse events
timeFrame: up to 24 weeks
measure: laboratory test
timeFrame: up to 12 weeks
measure: vital signs
timeFrame: up to 12 weeks
measure: residual urine
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: KYU-SUNG LEE, M.D.
role: PRINCIPAL_INVESTIGATOR
References: