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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THVD-201 | Experimental | 1. Treatment period(12 weeks)
2. Open-label extension period(An additional 12 weeks)
|
|
| Tolterodine (Detrusitol) | Active Comparator | 1. Treatment period(12 weeks)
2. Open-label extension period(An additional 12 weeks)
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THVD-201 | Drug | Combination of Tolterodine 2mg and Pilocarpine 9mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean daily micturition frequency | The change of Mean daily micturition frequency between 0 and 12 weeks | 12 weeks |
| ADR Incidence of Dry mouth | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean daily micturition frequency | The change of Mean daily micturition frequency between 0 and 24 weeks | 24 weeks |
| Mean daily Incontinence frequency(12 weeks) | The change of Mean daily Incontinence frequency between 0 and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyu Sung Lee | Samsung Medical Center (SMC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | South Korea | ||||
| Dankook University Hospital |
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| Placebo(For THVD-201) | Drug |
|
| Detrusitol 2mg tablet | Drug | Tolterodine 2mg |
|
| Placebo(For Detrusitol 2mg tablet) | Drug |
|
| 12 weeks |
| Mean daily Incontinence frequency(24 weeks) | The change of Mean daily Incontinence frequency between 0 and 24 weeks | 24 weeks |
| Mean daily Urgency frequency(12 weeks) | The change of Mean daily Urgency frequency between 0 and 12 weeks | 12 weeks |
| Mean daily Urgency frequency(24 weeks) | The change of Mean daily Urgency frequency between 0 and 24 weeks | 24 weeks |
| Mean daily Nocturia frequency(12 weeks) | The change of Mean daily Nocturia frequency between 0 and 12 weeks | 12 weeks |
| Mean daily Nocturia frequency(24 weeks) | The change of Mean daily Nocturia frequency between 0 and 24 weeks | 24 weeks |
| Mean daily Micturition volume(12 weeks) | The change of Mean daily Micturition volume between 0 and 12 weeks | 12 weeks |
| Mean daily Micturition volume(24 weeks) | The change of Mean daily Micturition volume between 0 and 24 weeks | 24 weeks |
| Score of OAB-SS questionnaire(12 weeks) | The change of the Score between 0 and 12 weeks | 12 weeks |
| Score of OAB-SS questionnaire(24 weeks) | The change of the Score between 0 and 24 weeks | 24 weeks |
| Score of OAB-q questionnaire(12 weeks) | The change of the Score between 0 and 12 weeks | 12 weeks |
| Score of OAB-q questionnaire(24 weeks) | The change of the Score between 0 and 24 weeks | 24 weeks |
| VAS score of dry mouth symptom(12 weeks) | The change of the Score between 0 and 12 weeks | 12 weeks |
| VAS score of dry mouth symptom(24 weeks) | The change of the Score between 0 and 24 weeks | 24 weeks |
| Score of Xerostomia Inventory questionnaire(12 weeks) | The change of the Score between 0 and 12 weeks | 12 weeks |
| Score of Xerostomia Inventory questionnaire(24 weeks) | The change of the Score between 0 and 24 weeks | 24 weeks |
| Cheonan |
| South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| 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 |
| Korea University Anam Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| The Catholic University of Korea, Bucheon ST. Mary's Hospital | Seoul | South Korea |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068737 | Tolterodine Tartrate |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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