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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00212732

Enrollment

750

Registered

2005-09-21

Start date

2003-10-31

Completion date

Unknown

Last updated

2012-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Keywords

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

Brief summary

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

Interventions

DRUGONO-8025 (KRP-197)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Total number of urinary incontinence episodes per week	—

Secondary

Measure	Time frame
Number of micturition per day, number of urinary urgency episodes per day, volume voided per micturition and QOL	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026