A Confirmatory Study of KUC-7483 in Patients With Overactive Bladder
Overview
To evaluate the efficacy and the safety of KUC-7483 in overactive bladder patients.
Full Title of Study: “A Randomized, Double Blind, Placebo Controlled, Phase III Study of KUC-7483 in Patients With Overactive Bladder”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
Interventions
- Drug: KUC-7483
- Drug: Placebo
- Drug: Tolterodine
Arms, Groups and Cohorts
- Experimental: KUC-7483
- Placebo Comparator: Placebo
- Active Comparator: Tolterodine
Clinical Trial Outcome Measures
Primary Measures
- Change from baseline in the mean number of micturitions per 24 hours
- Time Frame: 12 weeks
Secondary Measures
- Change from baseline in the mean number of urgency episodes per 24 hours
- Time Frame: 12 weeks
- Change from baseline in the mean number of incontinence episodes per 24 hours
- Time Frame: 12 weeks
Participating in This Clinical Trial
Inclusion Criteria
- Patients with a symptom of overactive bladder for more than 6 months. – Patients who meet the following condition during the 3-day bladder diary period. – the mean number of micturitions per 24 hours is ≥8 times – the mean number of urgency episodes per 24 hours is ≥1 time Exclusion Criteria:
- Patients who are diagnosed as stress urinary incontinence are predominant. – Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.
Gender Eligibility: All
Minimum Age: 20 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Overall Official(s)
- Yasuhiro Omori, Study Director, Clinical Development Department, Kissei pharmaceutical Co., Ltd.
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