Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Criteria
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 exclusion criteria as specified in the study protocol