Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder
Phase 3
Completed
- Conditions
- Overactive Bladder
- Interventions
- Drug: imidafenacin, KRP-197/ONO-8025
- Registration Number
- NCT00512785
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief Summary
The purpose of this study is to evaluate the long-term safety and efficacy of imidafenacin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 435
Inclusion Criteria
- Men and Woman equal or > 20 years old
- Patients with urgency, urinary frequency and urgency incontinence
Exclusion Criteria
- Patients with genuine stress incontinence
- Patients suffering from complications such as bladder tumor, urinary tract stone and symptomatic urinary tract infection
- Patients suffering from complications contraindicating the use of antimuscarinic medication
- Patients with polyuria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description E1 imidafenacin, KRP-197/ONO-8025 - E2 imidafenacin, KRP-197/ONO-8025 -
- Primary Outcome Measures
Name Time Method Safety Measures: adverse events, laboratory tests, 12-lead ECG, vital signs, post-void residual volume 64 weeks
- Secondary Outcome Measures
Name Time Method Efficacy measures: number of urgency incontinence episodes per week, number of incontinence episodes per week, number of micturitions per day, number of urgency episodes per day, severity of urgency, urine volume voided per micturition, Quality of Life 64 weeks
Trial Locations
- Locations (2)
Kinki Region
🇯🇵Kinki, Japan
Kanto Region
🇯🇵Kanto, Japan