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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578304
• Other study ID #: LG-IFCL002
• Status: Completed
• Phase: Phase 4
• First received: April 12, 2012
• Last updated: April 13, 2012
• Start date: December 2010
• Est. completion date: October 2011

Study information

• Verified date: April 2012
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Imidafenacin
Tablet, 12 weeks twice daily
• Fesoterodine
Tablet, 12 weeks once daily

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
LG Life Sciences	Kyorin Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Adverse events		up to 24 weeks	Yes
Secondary	laboratory test		up to 12 weeks	Yes
Secondary	vital signs		up to 12 weeks	Yes
Secondary	residual urine		up to 12 weeks	Yes