search
Back to results

Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
imidafenacin, KRP-197/ONO-8025
imidafenacin, KRP-197/ONO-8025
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Imidafenacin, KRP-197/ONO-8025, overactive bladder, antimuscarinic

Eligibility Criteria

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

Inclusion Criteria:

  • Men and Woman equal or > 20 years old
  • Patients with urgency, urinary frequency and urgency incontinence

Exclusion Criteria:

  • Patients with genuine stress incontinence
  • Patients suffering from complications such as bladder tumor, urinary tract stone and symptomatic urinary tract infection
  • Patients suffering from complications contraindicating the use of antimuscarinic medication
  • Patients with polyuria

Sites / Locations

  • Kanto Region
  • Kinki Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

E1

E2

Arm Description

Outcomes

Primary Outcome Measures

Safety Measures: adverse events, laboratory tests, 12-lead ECG, vital signs, post-void residual volume

Secondary Outcome Measures

Efficacy measures: number of urgency incontinence episodes per week, number of incontinence episodes per week, number of micturitions per day, number of urgency episodes per day, severity of urgency, urine volume voided per micturition, Quality of Life

Full Information

First Posted
August 7, 2007
Last Updated
June 12, 2012
Sponsor
Ono Pharmaceutical Co. Ltd
Collaborators
Kyorin Pharmaceutical Co.,Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT00512785
Brief Title
Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder
Official Title
An Open-label Study to Evaluate the Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd
Collaborators
Kyorin Pharmaceutical Co.,Ltd

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the long-term safety and efficacy of imidafenacin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Imidafenacin, KRP-197/ONO-8025, overactive bladder, antimuscarinic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
435 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E1
Arm Type
Experimental
Arm Title
E2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
imidafenacin, KRP-197/ONO-8025
Intervention Description
0.1 mg BID for 52 weeks
Intervention Type
Drug
Intervention Name(s)
imidafenacin, KRP-197/ONO-8025
Intervention Description
0.1 mg BID for 12 weeks and 0.2 mg BID for 52 weeks
Primary Outcome Measure Information:
Title
Safety Measures: adverse events, laboratory tests, 12-lead ECG, vital signs, post-void residual volume
Time Frame
64 weeks
Secondary Outcome Measure Information:
Title
Efficacy measures: number of urgency incontinence episodes per week, number of incontinence episodes per week, number of micturitions per day, number of urgency episodes per day, severity of urgency, urine volume voided per micturition, Quality of Life
Time Frame
64 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and Woman equal or > 20 years old Patients with urgency, urinary frequency and urgency incontinence Exclusion Criteria: Patients with genuine stress incontinence Patients suffering from complications such as bladder tumor, urinary tract stone and symptomatic urinary tract infection Patients suffering from complications contraindicating the use of antimuscarinic medication Patients with polyuria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshifumi Hirahara
Organizational Affiliation
Kyorin Pharmaceutical Co.,Ltd
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Toshihiko Konomi
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Chair
Facility Information:
Facility Name
Kanto Region
City
Kanto
Country
Japan
Facility Name
Kinki Region
City
Kinki
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder

We'll reach out to this number within 24 hrs