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NCT00212732 Clinical Trial

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

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00212732
Other study ID # ONO-8025-08
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated October 10, 2012
Start date October 2003

Study information
Verified date October 2012
Source Ono Pharmaceutical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.

Recruitment information / eligibility
Status Completed
Enrollment 750
Est. completion date
Est. primary completion date April 2006
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

1. Patients who are 20 years old or over with overactive bladder

2. Total number of urinary incontinence episodes per week is 5 or over

3. Mean number of micturition per day is 8 or over

4. Mean number of urinary urgency episodes per day is 1 or over

5. Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

1. Patients with genuine stress incontinence

2. Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection

3. Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study

4. Patients suffering from complications for which anticholinergics are contraindicated

5. Other exlcusion criteria as specified in the study protocol

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ONO-8025 (KRP-197)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ono Pharmaceutical Co. Ltd

Outcome
Type Measure Description Time frame Safety issue
Primary Total number of urinary incontinence episodes per week
Secondary Number of micturition per day, number of urinary urgency episodes per day, volume voided per micturition and QOL
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