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

This study has been completed.
Sponsor:
Collaborator:
Kyorin Pharmaceutical Co.,Ltd
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01578304
First received: April 12, 2012
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
Drug: Imidafenacin
Drug: Fesoterodine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase IV Study to Evaluate the Efficacy and Safety Imidafenacin Versus Fesoterodine in Patients With Overactive Bladder

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Difference in daily mean urination frequency between the end of treatment period(Week 12) and the end of observation period(Baseline, Week 0) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
  • laboratory test [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • vital signs [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • residual urine [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 207
Study Start Date: December 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imidafenacin Drug: Imidafenacin
Tablet, 12 weeks twice daily
Active Comparator: Fesoterodine Drug: Fesoterodine
Tablet, 12 weeks once daily

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578304

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
LG Life Sciences
Kyorin Pharmaceutical Co.,Ltd
Investigators
Principal Investigator: KYU-SUNG LEE, M.D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01578304     History of Changes
Other Study ID Numbers: LG-IFCL002
Study First Received: April 12, 2012
Last Updated: April 13, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by LG Life Sciences:
Overactive bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014