Overactive Bladder
Conditions
Keywords
Overactive Bladder, Tolterodine (Detrusitol), Pilocarpine
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.
Interventions
DRUGTHVD-201
Combination of Tolterodine 2mg and Pilocarpine 9mg
DRUGPlacebo(For THVD-201)
DRUGDetrusitol 2mg tablet
Tolterodine 2mg
DRUGPlacebo(For Detrusitol 2mg tablet)
Sponsors
SK Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean daily micturition frequency | 12 weeks | The change of Mean daily micturition frequency between 0 and 12 weeks |
| ADR Incidence of Dry mouth | 12 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean daily Incontinence frequency(24 weeks) | 24 weeks | The change of Mean daily Incontinence frequency 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 Urgency frequency(24 weeks) | 24 weeks | The change of Mean daily Urgency 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 |
| Mean daily Micturition volume(24 weeks) | 24 weeks | The change of Mean daily Micturition volume between 0 and 24 weeks |
| Mean daily micturition frequency | 24 weeks | The change of Mean daily micturition frequency between 0 and 24 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(12 weeks) | 12 weeks | The change of the Score between 0 and 12 weeks |
| Score of OAB-q questionnaire(24 weeks) | 24 weeks | The change of the Score between 0 and 24 weeks |
| VAS score of dry mouth symptom(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 |
| Score of Xerostomia Inventory questionnaire(12 weeks) | 12 weeks | The change of the Score between 0 and 12 weeks |
| Score of Xerostomia Inventory questionnaire(24 weeks) | 24 weeks | The change of the Score between 0 and 24 weeks |
| Score of OAB-SS questionnaire(12 weeks) | 12 weeks | The change of the Score 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 |
Countries
South Korea
Outcome results
None listed