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A Phase II Study of KUC-7483 in Patients With Overactive Bladder

Primary Purpose

Overactive Bladder (OAB)

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KUC-7483
Placebo
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 (OAB) focused on measuring Overactive bladder, Frequency, Micturition, Urgency, Urge urinary incontinence, β3-agonist

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
  • Japan
  • Japan
  • Japan
  • Japan
  • Japan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

3

1

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in mean number of micturitions per 24 hours

Secondary Outcome Measures

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

Full Information

First Posted
August 5, 2008
Last Updated
September 2, 2009
Sponsor
Kissei Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00742833
Brief Title
A Phase II Study of KUC-7483 in Patients With Overactive Bladder
Official Title
A Randomized, Double Blind, Placebo Controlled, Phase II Study of KUC-7483 in Patients With Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
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 investigate the efficacy and 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 (OAB)
Keywords
Overactive bladder, Frequency, Micturition, Urgency, Urge urinary incontinence, β3-agonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3
Arm Type
Experimental
Arm Title
1
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
KUC-7483
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in mean number of micturitions per 24 hours
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in mean number of urgency episodes per 24 hours
Time Frame
12 weeks
Title
Change from baseline in 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
Kissei Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Japan
City
Hokkaido region
Country
Japan
Facility Name
Japan
City
Kansai region
Country
Japan
Facility Name
Japan
City
Kanto region
Country
Japan
Facility Name
Japan
City
Kyushu region
Country
Japan
Facility Name
Japan
City
Shikoku region
Country
Japan
Facility Name
Japan
City
Tohoku region
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

A Phase II Study of KUC-7483 in Patients With Overactive Bladder

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