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.
NCT01458197 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 235
Last updated 2014-03-12
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. .
Conditions
Interventions
- DRUG
-
Tarafenacin 0.2 mg
Capsule, qd, 12 weeks
- DRUG
-
Capsule, qd, 12 weeks
- DRUG
-
Tarafenacin 0.4 mg
Capsule, qd, 12 weeks
Sponsors & Collaborators
-
Kwang Dong Pharmaceutical co., ltd.
lead INDUSTRY
Principal Investigators
-
Myung-Soo Choo, Professor · Asan Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-09-30
- Primary Completion
- 2012-08-31
- Completion
- 2012-11-30
Countries
- South Korea
Study Locations
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