Status:
COMPLETED
Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Overactive Bladder
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.
Eligibility Criteria
Inclusion
- Patients who are 20 years old or over with overactive bladder
- Total number of urinary incontinence episodes per week is 5 or over
- Mean number of micturition per day is 8 or over
- Mean number of urinary urgency episodes per day is 1 or over
- Other inclusion criteria as specified in the study protocol
Exclusion
- Patients with genuine stress incontinence
- Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection
- Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study
- Patients suffering from complications for which anticholinergics are contraindicated
- Other exlcusion criteria as specified in the study protocol
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT00212732
Start Date
October 1 2003
Last Update
October 11 2012
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