Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

ONO-8025 (KRP-197)

About this trial

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

Eligibility Criteria

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

Inclusion Criteria: Patients who are 20 years old or over with overactive bladder Total number of urinary incontinence episodes per week is 5 or over Mean number of micturition per day is 8 or over Mean number of urinary urgency episodes per day is 1 or over Other inclusion criteria as specified in the study protocol Exclusion Criteria: Patients with genuine stress incontinence Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study Patients suffering from complications for which anticholinergics are contraindicated Other exlcusion criteria as specified in the study protocol

Sites / Locations

Outcomes

Primary Outcome Measures

Total number of urinary incontinence episodes per week

Secondary Outcome Measures

Number of micturition per day, number of urinary urgency episodes per day, volume voided per micturition and QOL

Full Information

NCT ID

NCT00212732

First Posted

September 13, 2005

Last Updated

October 10, 2012

Sponsor

Ono Pharmaceutical Co. Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00212732

Brief Title

Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan

Official Title

Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

April 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ono Pharmaceutical Co. Ltd

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) 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

ONO-8025, KRP-197, overactive bladder, antimuscarinic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

750 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

ONO-8025 (KRP-197)

Primary Outcome Measure Information:

Title

Total number of urinary incontinence episodes per week

Secondary Outcome Measure Information:

Title

Number of micturition per day, number of urinary urgency episodes per day, volume voided per micturition and QOL

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients who are 20 years old or over with overactive bladder Total number of urinary incontinence episodes per week is 5 or over Mean number of micturition per day is 8 or over Mean number of urinary urgency episodes per day is 1 or over Other inclusion criteria as specified in the study protocol Exclusion Criteria: Patients with genuine stress incontinence Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study Patients suffering from complications for which anticholinergics are contraindicated Other exlcusion criteria as specified in the study protocol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Project Leader, Development Planning

Organizational Affiliation

Ono Pharmaceutical Co. Ltd

Official's Role

Study Director

Overactive Bladder

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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