A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder.
Phase 2
Completed
- Conditions
- Overactive Bladder
- Interventions
- Drug: Tarafenacin 0.4 mgDrug: PlaceboDrug: Tarafenacin 0.2 mg
- Registration Number
- NCT01458197
- Lead Sponsor
- Kwang Dong Pharmaceutical co., ltd.
- Brief Summary
1. Primary Objective:
To evaluate the dose-response relationship of tarafenacin on efficacy.
2. Secondary Objectives:
* To compare 12 weeks' efficacy of different doses of tarafenacin to that of placebo in patients suffering from Overactive Bladder. .
* To compare the tolerability of different doses of tarafenacin to that of placebo in patients suffering from Overactive Bladder. .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 235
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tarafenacin 0.4 mg Tarafenacin 0.4 mg Group 2 Placebo Placebo Group 3 Tarafenacin 0.2 mg Tarafenacin 0.2 mg Group 1
- Primary Outcome Measures
Name Time Method the change in the number of micturitions per 24 hours from baseline to the end of the 12 weeks treatment period 12 weeks
- Secondary Outcome Measures
Name Time Method Mean change from baseline to 12weeks in Number of urgency episodes 12 weeks Mean change from baseline to 12weeks in Number of incontinence episodes 12 weeks Mean change from baseline to 12weeks in Number of nocturia episodes 12weeks Mean change from baseline to 12weeks in Volume of urine passed per void 12weeks Mean change from baseline to 12weeks in score of King's Health Questionnaire 12weeks
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of