A Randomized, Double-Blind, Parallel-Group Study of SMP-986 in Patients with Overactive Bladder [Phase 2 Study]
Phase 2
- Conditions
- Overactive bladder
- Registration Number
- JPRN-jRCT2080221224
- Lead Sponsor
- Dainippon Sumitomo Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 320
Inclusion Criteria
Patient with overactive bladder who meets the following criteria
-Outpatient
-Patient has overactive bladder syndrome over a successive period of at least 6 months prior to onset of the study
-Patient can get to a bathroom without assistance and can record the bladder diary accurately
Exclusion Criteria
-Patient with bladder outlet obstruction
-Patient has a neurological disease which has potential to cause overactive bladder syndrome
-Patient has a polyuria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: Change from baseline in number of voids per day<br>At 12 weeks
- Secondary Outcome Measures
Name Time Method Efficacy: Change from baseline in number of urgency episodes per day<br>At 12 weeks