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

Primary Purpose

Overactive Bladder

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Imidafenacin

Fesoterodine

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive bladder

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Imidafenacin

Fesoterodine

Arm Description

Outcomes

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)

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)

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)

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)

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)

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)

Adverse events

laboratory test

vital signs

residual urine

Full Information

NCT ID

NCT01578304

First Posted

April 12, 2012

Last Updated

April 13, 2012

Sponsor

LG Life Sciences

Collaborators

Kyorin Pharmaceutical Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01578304

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LG Life Sciences

Collaborators

Kyorin Pharmaceutical Co.,Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

Keywords

Overactive bladder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

207 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Imidafenacin

Arm Type

Experimental

Arm Title

Fesoterodine

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Imidafenacin

Intervention Description

Tablet, 12 weeks twice daily

Intervention Type

Drug

Intervention Name(s)

Fesoterodine

Intervention Description

Tablet, 12 weeks once daily

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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

Title

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

Title

Adverse events

Time Frame

up to 24 weeks

Title

laboratory test

Time Frame

up to 12 weeks

Title

vital signs

Time Frame

up to 12 weeks

Title

residual urine

Time Frame

up to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

KYU-SUNG LEE, M.D.

Organizational Affiliation

Samsung Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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