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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Fesoterodine
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 20, 2014