Back to resultsLong-term Safety and Efficacy of KUC-7483 in Patients With Overactive Bladder
Primary Purpose
Overactive Bladder
Status
Withdrawn
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KUC-7483
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive bladder, Frequency, Micturition, Urgency, Urge urinary incontinence, OAB
Eligibility Criteria
Inclusion Criteria:
- Patients who have successfully completed the Phase III double-blind study.
Exclusion Criteria:
- Patients with serious adverse events or clinically significant adverse events in the Phase III double-blind study.
Sites / Locations
- Japan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KUC-7483
Arm Description
Outcomes
Primary Outcome Measures
The long-term safety of KUC-7483 for the treatment of overactive bladder.
Secondary Outcome Measures
The long-term efficacy of KUC-7483 for the treatment of overactive bladder.
Full Information
NCT ID
NCT01003405
First Posted
October 27, 2009
Last Updated
July 25, 2010
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01003405
Brief Title
Long-term Safety and Efficacy of KUC-7483 in Patients With Overactive Bladder
Official Title
A Open-label, Long-term Extension Study of KUC-7483 in Patients With Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the long-term safety, efficacy and pharmacokinetics of KUC-7483 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, Frequency, Micturition, Urgency, Urge urinary incontinence, OAB
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KUC-7483
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KUC-7483
Primary Outcome Measure Information:
Title
The long-term safety of KUC-7483 for the treatment of overactive bladder.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
The long-term efficacy of KUC-7483 for the treatment of overactive bladder.
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have successfully completed the Phase III double-blind study.
Exclusion Criteria:
Patients with serious adverse events or clinically significant adverse events in the Phase III double-blind study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasuhiro Omori
Organizational Affiliation
Clinical Development Department, Kissei pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Japan
City
Hokkaido,Tohoku,Kanto,Chubu,Kansai,Shikoku,Kyushu
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Long-term Safety and Efficacy of KUC-7483 in Patients With Overactive Bladder
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