Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-02-10 @ 4:52 PM
Study NCT ID:
NCT02303769
Status:
COMPLETED
Last Update Posted:
2016-02-25
First Post:
2014-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1tablet and Harnal-D - Tablet in BPH Patients With LUTS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077409', 'term': 'Tamsulosin'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 309}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-24', 'studyFirstSubmitDate': '2014-11-11', 'studyFirstSubmitQcDate': '2014-11-28', 'lastUpdatePostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to endpoint in total International Prostate Symptom Score', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to endpoint in total International Prostate Symptom Score', 'timeFrame': '4 weeks'}, {'measure': 'Change from baseline to endpoint in voiding score', 'timeFrame': '4 weeks, 8 weeks'}, {'measure': 'Change from baseline to endpoint in IPSS QoL', 'timeFrame': '4 weeks, 8 weeks'}, {'measure': 'Change from baseline to endpoint in Qmax', 'timeFrame': '4 weeks, 8 weeks'}, {'measure': 'Change from baseline to endpoint in PVR', 'timeFrame': '4 weeks, 8 weeks'}, {'measure': 'Time to event/proportion of subjects with AUR', 'timeFrame': '8 weeks'}, {'measure': 'Time to event/proportion of subjects undergoing BPH related prostatic surgery', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lower Urinary Track Syndrome', 'Harnal', 'Tamsulosin HCL 0.4mg'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'Study to investigate the efficacy and safety of GL2702 GLARS-NF1tablet and Harnal-D - tablet in benign prostatic hyperplasia patients with lower urinary tract symptomatic', 'detailedDescription': 'GL2702 GLARS-NF1 tablet is controlled released formation which is made by GL Pharm Tech'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 50 years old, BPH diagnosted, Adult Male Subject\n* IPSS ≥ 13 point\n* PSA \\< 4ng/mL\n* 5ml/sec \\< Qmax ≤ 15ml/sec\n\nExclusion Criteria:\n\n* Prostatic cancer\n* 250ml \\< PVR\n* ALT or AST \\> 2 times (Upper Normal Range)\n* Total Bilirubin \\> 1.5 times (Upper Normal Range)\n* Treated with α-adrenalin receptor blocker within 2weeks before screening\n* Treated with 5Alpha-Reductase Inhibitor within 6 months before screening\n* Treated with phytotherapy within 2weeks before screening\n* Treated with Anabolic Steroid within 6 months before screening'}, 'identificationModule': {'nctId': 'NCT02303769', 'acronym': 'GL2702', 'briefTitle': 'Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1tablet and Harnal-D - Tablet in BPH Patients With LUTS', 'organization': {'class': 'INDUSTRY', 'fullName': 'GL Pharm Tech Corporation'}, 'officialTitle': 'A Multicenter, Randomized, Double -Blind, Parallel, Comparative, Phase III Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1 Tablet in BPH Patients With LUTS', 'orgStudyIdInfo': {'id': 'GL2702-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tamsulosin HCL 0.2mg', 'description': 'Harnal-D tablet (Tamsulosin HCL 0.2mg)', 'interventionNames': ['Drug: Tamsulosin HCL 0.2mg']}, {'type': 'EXPERIMENTAL', 'label': 'Tamsulosin HCL 0.4mg', 'description': 'GL2702 GLARS-NF1 tablet (Tamsulosin HCL 0.4mg)', 'interventionNames': ['Drug: Tamsulosin HCL 0.4mg']}], 'interventions': [{'name': 'Tamsulosin HCL 0.4mg', 'type': 'DRUG', 'otherNames': ['GL2702 GLARS-NF1 Tablet'], 'description': 'Tamsulosin HCL 0.4mg once a day', 'armGroupLabels': ['Tamsulosin HCL 0.4mg']}, {'name': 'Tamsulosin HCL 0.2mg', 'type': 'DRUG', 'otherNames': ['Harmal D'], 'description': 'Tamsulosin HCL 0.2mg once a day', 'armGroupLabels': ['Tamsulosin HCL 0.2mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eulji general hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'You T Gun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eulji General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GL Pharm Tech Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}