Clinical Study to Assess the Efficacy and Safety of THVD-201 in Patients With OAB
- Conditions
- Overactive Bladder
- Interventions
- Drug: Placebo(For Detrusitol 2mg tablet)Drug: Placebo(For THVD-201)
- Registration Number
- NCT02485067
- Lead Sponsor
- SK Chemicals Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 384
- 20 - 85 years
- History of OAB (pure urge or mixed urinary incontinence with predominant urge incontinence) for ≥ 6 months.
- In the case of females, at least 2 years has passed since menopause. Or all pre-menopausal female subjects must have been using a highly effective method of birth control during the study. Subject of childbearing potential must have had a negative pregnancy test prior to enrollment.
- Predominate stress incontinence, insensate incontinence (those incapable of distinguishing discrete incontinence episodes) and overflow incontinence, as major reason for urine loss or urinary frequency as determined by the investigator.
- History of neurogenic bladder.
- PVR > 200mL
- History of clinically significant renal disease or estimated creatinine clearance defined by Cockcroft and Gault formula < 30 mL/min.
- History of malignant tumor within the past 5 years.
- History or presence of tachyarrhythmia or cardiac disease that in the opinion of the investigator might have confounded the results of the study or posed additional risk to the subject. Subjects who had a value for QTc > 450 msec at the Screening visit.
- Patient with asthma
- PSA ≥ 10 ng/mL in male who is 50 years and over.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description THVD-201 THVD-201 1. Treatment period(12 weeks) 1. Double dummy(A+B) A. THVD-201: capsule B. Placebo(For Detrusitol 2mg tablet) 2. One capsule and One tablet bid on an empty stomach 2. Open-label extension period(An additional 12 weeks) 1. Regardless of the previous type of arm, all patients only take THVD-201 during this period. 2. One capsule bid on an empty stomach THVD-201 Placebo(For Detrusitol 2mg tablet) 1. Treatment period(12 weeks) 1. Double dummy(A+B) A. THVD-201: capsule B. Placebo(For Detrusitol 2mg tablet) 2. One capsule and One tablet bid on an empty stomach 2. Open-label extension period(An additional 12 weeks) 1. Regardless of the previous type of arm, all patients only take THVD-201 during this period. 2. One capsule bid on an empty stomach Tolterodine (Detrusitol) Detrusitol 2mg tablet 1. Treatment period(12 weeks) 1. Double dummy(A+B) A. Placebo(For THVD-201): capsule B. Detrusitol 2mg tablet 2. One capsule and One tablet bid on an empty stomach 2. Open-label extension period(An additional 12 weeks) 1. Regardless of the previous type of arm , all patients only take THVD-201 during this period. 2. One capsule bid on an empty stomach Tolterodine (Detrusitol) THVD-201 1. Treatment period(12 weeks) 1. Double dummy(A+B) A. Placebo(For THVD-201): capsule B. Detrusitol 2mg tablet 2. One capsule and One tablet bid on an empty stomach 2. Open-label extension period(An additional 12 weeks) 1. Regardless of the previous type of arm , all patients only take THVD-201 during this period. 2. One capsule bid on an empty stomach Tolterodine (Detrusitol) Placebo(For THVD-201) 1. Treatment period(12 weeks) 1. Double dummy(A+B) A. Placebo(For THVD-201): capsule B. Detrusitol 2mg tablet 2. One capsule and One tablet bid on an empty stomach 2. Open-label extension period(An additional 12 weeks) 1. Regardless of the previous type of arm , all patients only take THVD-201 during this period. 2. One capsule bid on an empty stomach
- Primary Outcome Measures
Name Time Method ADR Incidence of Dry mouth 12 weeks Mean daily micturition frequency 12 weeks The change of Mean daily micturition frequency between 0 and 12 weeks
- Secondary Outcome Measures
Name Time Method VAS score of dry mouth symptom(12 weeks) 12 weeks The change of the Score between 0 and 12 weeks
Mean daily micturition frequency 24 weeks The change of Mean daily micturition frequency between 0 and 24 weeks
Mean daily Incontinence frequency(24 weeks) 24 weeks The change of Mean daily Incontinence frequency between 0 and 24 weeks
Mean daily Nocturia frequency(12 weeks) 12 weeks The change of Mean daily Nocturia frequency between 0 and 12 weeks
Mean daily Nocturia frequency(24 weeks) 24 weeks The change of Mean daily Nocturia frequency between 0 and 24 weeks
Mean daily Micturition volume(12 weeks) 12 weeks The change of Mean daily Micturition volume between 0 and 12 weeks
Score of OAB-SS questionnaire(12 weeks) 12 weeks The change of the Score between 0 and 12 weeks
Score of OAB-SS questionnaire(24 weeks) 24 weeks The change of the Score between 0 and 24 weeks
Score of OAB-q questionnaire(24 weeks) 24 weeks The change of the Score between 0 and 24 weeks
Score of Xerostomia Inventory questionnaire(24 weeks) 24 weeks The change of the Score between 0 and 24 weeks
Mean daily Urgency frequency(12 weeks) 12 weeks The change of Mean daily Urgency frequency between 0 and 12 weeks
Mean daily Incontinence frequency(12 weeks) 12 weeks The change of Mean daily Incontinence frequency between 0 and 12 weeks
Mean daily Urgency frequency(24 weeks) 24 weeks The change of Mean daily Urgency frequency between 0 and 24 weeks
Mean daily Micturition volume(24 weeks) 24 weeks The change of Mean daily Micturition volume between 0 and 24 weeks
Score of OAB-q questionnaire(12 weeks) 12 weeks The change of the Score between 0 and 12 weeks
Score of Xerostomia Inventory questionnaire(12 weeks) 12 weeks The change of the Score between 0 and 12 weeks
VAS score of dry mouth symptom(24 weeks) 24 weeks The change of the Score between 0 and 24 weeks
Trial Locations
- Locations (16)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Bucheon ST. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Dankook University Hospital
🇰🇷Cheonan, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Ajou University Medical Center
🇰🇷Seoul, Korea, Republic of
Cheil General Hospital
🇰🇷Seoul, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Seoul, Korea, Republic of
Bundang Cha Medical center
🇰🇷Seongnam, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul ST. Mary's Hospital
🇰🇷Seoul, Korea, Republic of