search
Back to results

A Confirmatory Study of KUC-7483 in Patients With Overactive Bladder

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KUC-7483
Placebo
Tolterodine
Sponsored by
Kissei 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 Overactive bladder, Frequency, Micturition, Urgency, Urge urinary incontinence, OAB

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with a symptom of overactive bladder for more than 6 months.

  • Patients who meet the following condition during the 3-day bladder diary period.

    • the mean number of micturitions per 24 hours is ≥8 times
    • the mean number of urgency episodes per 24 hours is ≥1 time

Exclusion Criteria:

  • Patients who are diagnosed as stress urinary incontinence are predominant.
  • Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.

Sites / Locations

  • Japan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

KUC-7483

Placebo

Tolterodine

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in the mean number of micturitions per 24 hours

Secondary Outcome Measures

Change from baseline in the mean number of urgency episodes per 24 hours
Change from baseline in the mean number of incontinence episodes per 24 hours

Full Information

First Posted
October 27, 2009
Last Updated
July 25, 2010
Sponsor
Kissei Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01004315
Brief Title
A Confirmatory Study of KUC-7483 in Patients With Overactive Bladder
Official Title
A Randomized, Double Blind, Placebo Controlled, Phase III Study of KUC-7483 in Patients With Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
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 evaluate the efficacy and the safety of KUC-7483 in overactive bladder patients.

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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KUC-7483
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Tolterodine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
KUC-7483
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Tolterodine
Primary Outcome Measure Information:
Title
Change from baseline in the mean number of micturitions per 24 hours
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in the mean number of urgency episodes per 24 hours
Time Frame
12 weeks
Title
Change from baseline in the mean number of incontinence episodes per 24 hours
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a symptom of overactive bladder for more than 6 months. Patients who meet the following condition during the 3-day bladder diary period. the mean number of micturitions per 24 hours is ≥8 times the mean number of urgency episodes per 24 hours is ≥1 time Exclusion Criteria: Patients who are diagnosed as stress urinary incontinence are predominant. Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.
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

A Confirmatory Study of KUC-7483 in Patients With Overactive Bladder

We'll reach out to this number within 24 hrs