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 3
• 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 exlcusion criteria as specified in the study protocol