NCT01578304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2012

Completed
Last Updated

April 16, 2012

Status Verified

April 1, 2012

Enrollment Period

10 months

First QC Date

April 12, 2012

Last Update Submit

April 13, 2012

Conditions

Overactive Bladder

Keywords

Overactive bladder

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • 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

  • 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

  • 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

  • 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

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Imidafenacin

EXPERIMENTAL
Drug: Imidafenacin

Fesoterodine

ACTIVE COMPARATOR
Drug: Fesoterodine

Interventions

ImidafenacinDRUG

Tablet, 12 weeks twice daily

Imidafenacin
FesoterodineDRUG

Tablet, 12 weeks once daily

Fesoterodine

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • times or more of daily mean urination frequency
  • times or more of daily mean frequency of a sense of urinary urgency or 2 times or more of urge incontinence frequency

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

imidafenacinfesoterodine

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • KYU-SUNG LEE, M.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2012

First Posted

April 16, 2012

Study Start

December 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

April 16, 2012

Record last verified: 2012-04

Locations

KR(1)