Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-25 @ 12:15 AM
Study NCT ID:
NCT02485067
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2015-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Assess the Efficacy and Safety of THVD-201 in Patients With OAB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068737', 'term': 'Tolterodine Tartrate'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D010665', 'term': 'Phenylpropanolamine'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D003408', 'term': 'Cresols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 384}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-11', 'studyFirstSubmitDate': '2015-06-12', 'studyFirstSubmitQcDate': '2015-06-25', 'lastUpdatePostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean daily micturition frequency', 'timeFrame': '12 weeks', 'description': 'The change of Mean daily micturition frequency between 0 and 12 weeks'}, {'measure': 'ADR Incidence of Dry mouth', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Mean daily micturition frequency', 'timeFrame': '24 weeks', 'description': 'The change of Mean daily micturition frequency between 0 and 24 weeks'}, {'measure': 'Mean daily Incontinence frequency(12 weeks)', 'timeFrame': '12 weeks', 'description': 'The change of Mean daily Incontinence frequency between 0 and 12 weeks'}, {'measure': 'Mean daily Incontinence frequency(24 weeks)', 'timeFrame': '24 weeks', 'description': 'The change of Mean daily Incontinence frequency between 0 and 24 weeks'}, {'measure': 'Mean daily Urgency frequency(12 weeks)', 'timeFrame': '12 weeks', 'description': 'The change of Mean daily Urgency frequency between 0 and 12 weeks'}, {'measure': 'Mean daily Urgency frequency(24 weeks)', 'timeFrame': '24 weeks', 'description': 'The change of Mean daily Urgency frequency between 0 and 24 weeks'}, {'measure': 'Mean daily Nocturia frequency(12 weeks)', 'timeFrame': '12 weeks', 'description': 'The change of Mean daily Nocturia frequency between 0 and 12 weeks'}, {'measure': 'Mean daily Nocturia frequency(24 weeks)', 'timeFrame': '24 weeks', 'description': 'The change of Mean daily Nocturia frequency between 0 and 24 weeks'}, {'measure': 'Mean daily Micturition volume(12 weeks)', 'timeFrame': '12 weeks', 'description': 'The change of Mean daily Micturition volume between 0 and 12 weeks'}, {'measure': 'Mean daily Micturition volume(24 weeks)', 'timeFrame': '24 weeks', 'description': 'The change of Mean daily Micturition volume between 0 and 24 weeks'}, {'measure': 'Score of OAB-SS questionnaire(12 weeks)', 'timeFrame': '12 weeks', 'description': 'The change of the Score between 0 and 12 weeks'}, {'measure': 'Score of OAB-SS questionnaire(24 weeks)', 'timeFrame': '24 weeks', 'description': 'The change of the Score between 0 and 24 weeks'}, {'measure': 'Score of OAB-q questionnaire(12 weeks)', 'timeFrame': '12 weeks', 'description': 'The change of the Score between 0 and 12 weeks'}, {'measure': 'Score of OAB-q questionnaire(24 weeks)', 'timeFrame': '24 weeks', 'description': 'The change of the Score between 0 and 24 weeks'}, {'measure': 'VAS score of dry mouth symptom(12 weeks)', 'timeFrame': '12 weeks', 'description': 'The change of the Score between 0 and 12 weeks'}, {'measure': 'VAS score of dry mouth symptom(24 weeks)', 'timeFrame': '24 weeks', 'description': 'The change of the Score between 0 and 24 weeks'}, {'measure': 'Score of Xerostomia Inventory questionnaire(12 weeks)', 'timeFrame': '12 weeks', 'description': 'The change of the Score between 0 and 12 weeks'}, {'measure': 'Score of Xerostomia Inventory questionnaire(24 weeks)', 'timeFrame': '24 weeks', 'description': 'The change of the Score between 0 and 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Overactive Bladder', 'Tolterodine (Detrusitol)', 'Pilocarpine'], 'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 - 85 years\n* History of OAB (pure urge or mixed urinary incontinence with predominant urge incontinence) for ≥ 6 months.\n* 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.\n\nExclusion Criteria:\n\n* 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.\n* History of neurogenic bladder.\n* PVR \\> 200mL\n* History of clinically significant renal disease or estimated creatinine clearance defined by Cockcroft and Gault formula \\< 30 mL/min.\n* History of malignant tumor within the past 5 years.\n* 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.\n* Patient with asthma\n* PSA ≥ 10 ng/mL in male who is 50 years and over.'}, 'identificationModule': {'nctId': 'NCT02485067', 'briefTitle': 'Clinical Study to Assess the Efficacy and Safety of THVD-201 in Patients With OAB', 'organization': {'class': 'INDUSTRY', 'fullName': 'SK Chemicals Co., Ltd.'}, 'officialTitle': 'Multicenter, Randomized, Double-blind, Parallel, Active Control, Phase III Clinical Study to Assess the Efficacy and Safety of THVD-201 in Patients With Overactive Bladder Including an Open-label, Extension Study', 'orgStudyIdInfo': {'id': 'THVD-201_OAB_III_2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'THVD-201', 'description': '1\\. Treatment period(12 weeks)\n\n1. Double dummy(A+B) A. THVD-201: capsule B. Placebo(For Detrusitol 2mg tablet)\n2. One capsule and One tablet bid on an empty stomach\n\n2\\. Open-label extension period(An additional 12 weeks)\n\n1. Regardless of the previous type of arm, all patients only take THVD-201 during this period.\n2. One capsule bid on an empty stomach', 'interventionNames': ['Drug: THVD-201', 'Drug: Placebo(For Detrusitol 2mg tablet)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tolterodine (Detrusitol)', 'description': '1\\. Treatment period(12 weeks)\n\n1. Double dummy(A+B) A. Placebo(For THVD-201): capsule B. Detrusitol 2mg tablet\n2. One capsule and One tablet bid on an empty stomach\n\n2\\. Open-label extension period(An additional 12 weeks)\n\n1. Regardless of the previous type of arm , all patients only take THVD-201 during this period.\n2. One capsule bid on an empty stomach', 'interventionNames': ['Drug: THVD-201', 'Drug: Placebo(For THVD-201)', 'Drug: Detrusitol 2mg tablet']}], 'interventions': [{'name': 'THVD-201', 'type': 'DRUG', 'description': 'Combination of Tolterodine 2mg and Pilocarpine 9mg', 'armGroupLabels': ['THVD-201', 'Tolterodine (Detrusitol)']}, {'name': 'Placebo(For THVD-201)', 'type': 'DRUG', 'armGroupLabels': ['Tolterodine (Detrusitol)']}, {'name': 'Detrusitol 2mg tablet', 'type': 'DRUG', 'description': 'Tolterodine 2mg', 'armGroupLabels': ['Tolterodine (Detrusitol)']}, {'name': 'Placebo(For Detrusitol 2mg tablet)', 'type': 'DRUG', 'armGroupLabels': ['THVD-201']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Cheonan', 'country': 'South Korea', 'facility': 'Dankook University Hospital', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Bundang Cha Medical center', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ajou University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Cheil General Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Bucheon ST. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Seoul ST. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyu Sung Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center (SMC)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SK Chemicals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}