Overview
Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
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