The primary purpose of this study is to assess the efficacy and safety of THVD-201(Combination of tolterodine and pilocarpine) in patients with Overactive bladder during the period of treatment, 12 weeks. This study also includes an open label extension period of an additional 12 weeks following the treatment to assess long-term efficacy and safety of THVD-201 in patients with Overactive bladder.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
384
Combination of Tolterodine 2mg and Pilocarpine 9mg
Tolterodine 2mg
Inje University Busan Paik Hospital
Busan, South Korea
Dankook University Hospital
Cheonan, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Mean daily micturition frequency
The change of Mean daily micturition frequency between 0 and 12 weeks
Time frame: 12 weeks
ADR Incidence of Dry mouth
Time frame: 12 weeks
Mean daily micturition frequency
The change of Mean daily micturition frequency between 0 and 24 weeks
Time frame: 24 weeks
Mean daily Incontinence frequency(12 weeks)
The change of Mean daily Incontinence frequency between 0 and 12 weeks
Time frame: 12 weeks
Mean daily Incontinence frequency(24 weeks)
The change of Mean daily Incontinence frequency between 0 and 24 weeks
Time frame: 24 weeks
Mean daily Urgency frequency(12 weeks)
The change of Mean daily Urgency frequency between 0 and 12 weeks
Time frame: 12 weeks
Mean daily Urgency frequency(24 weeks)
The change of Mean daily Urgency frequency between 0 and 24 weeks
Time frame: 24 weeks
Mean daily Nocturia frequency(12 weeks)
The change of Mean daily Nocturia frequency between 0 and 12 weeks
Time frame: 12 weeks
Mean daily Nocturia frequency(24 weeks)
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Pusan National University Hospital
Pusan, South Korea
Bundang Cha Medical center
Seongnam, South Korea
Ajou University Medical Center
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Cheil General Hospital
Seoul, South Korea
Gachon University Gil Medical Center
Seoul, South Korea
Konkuk University Medical Center
Seoul, South Korea
...and 6 more locations
The change of Mean daily Nocturia frequency between 0 and 24 weeks
Time frame: 24 weeks
Mean daily Micturition volume(12 weeks)
The change of Mean daily Micturition volume between 0 and 12 weeks
Time frame: 12 weeks
Mean daily Micturition volume(24 weeks)
The change of Mean daily Micturition volume between 0 and 24 weeks
Time frame: 24 weeks
Score of OAB-SS questionnaire(12 weeks)
The change of the Score between 0 and 12 weeks
Time frame: 12 weeks
Score of OAB-SS questionnaire(24 weeks)
The change of the Score between 0 and 24 weeks
Time frame: 24 weeks
Score of OAB-q questionnaire(12 weeks)
The change of the Score between 0 and 12 weeks
Time frame: 12 weeks
Score of OAB-q questionnaire(24 weeks)
The change of the Score between 0 and 24 weeks
Time frame: 24 weeks
VAS score of dry mouth symptom(12 weeks)
The change of the Score between 0 and 12 weeks
Time frame: 12 weeks
VAS score of dry mouth symptom(24 weeks)
The change of the Score between 0 and 24 weeks
Time frame: 24 weeks
Score of Xerostomia Inventory questionnaire(12 weeks)
The change of the Score between 0 and 12 weeks
Time frame: 12 weeks
Score of Xerostomia Inventory questionnaire(24 weeks)
The change of the Score between 0 and 24 weeks
Time frame: 24 weeks