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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LG Life Sciences
• Collaborator: Kyorin Pharmaceutical Co.,Ltd
• Treatments: Fesoterodine

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