Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-24 @ 6:05 PM
Study NCT ID:
NCT01798667
Status:
UNKNOWN
Last Update Posted:
2013-08-15
First Post:
2013-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 in Male Patients With Premature Ejaculation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061686', 'term': 'Premature Ejaculation'}], 'ancestors': [{'id': 'D000097910', 'term': 'Ejaculatory Dysfunction'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C559089', 'term': 'DA 8031'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-08-14', 'studyFirstSubmitDate': '2013-01-27', 'studyFirstSubmitQcDate': '2013-02-22', 'lastUpdatePostDateStruct': {'date': '2013-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'average IELT change', 'timeFrame': 'From 0 week(baseline) to 8 week(end of treatment)'}], 'secondaryOutcomes': [{'measure': 'PEP, PGI', 'timeFrame': '8 weeks', 'description': 'PEP(Primary ejaculation profile), PGI(Patient-reported global impression)'}]}, 'conditionsModule': {'conditions': ['Premature Ejaculation']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the efficacy and safety of DA-8031 and to decide the optimal dose of DA-8031 in male patients with premature ejaculation after oral administration on-demand.\n\nThe investigators hypothesized that newly-developed DA-8031 would effect in delaying ejaculation in patients with premature ejaculation (PE).\n\nDesign:\n\nPlacebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients aged with premature ejaculation for more than 6 months.\n* PEDT score ≥ 11\n\nExclusion Criteria:\n\n* IIEF-EF domain ≤ 21\n* Serum Creatinine ≥ 2.5 mg/dl\n* AST, ALT \\> 3\\*Upper limit of normal\n* Subjects with hypotension(SBP/DBP\\<90/50mmHg) or uncontrolled hypertension(SBP/DBP\\>180/100mmHg)\n* Subjects with chronic depression, psychiatric or schizophrenia,\n* Subjects with alcohol, drug or substance abuse'}, 'identificationModule': {'nctId': 'NCT01798667', 'briefTitle': 'Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 in Male Patients With Premature Ejaculation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Double-dummy, Placebo-controlled, Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 After Oral Administration in Male Patients With Premature Ejaculation', 'orgStudyIdInfo': {'id': 'DA8031_PE_II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'PO administration', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'DA-8031 dose 1', 'description': 'PO administration', 'interventionNames': ['Drug: DA-8031']}, {'type': 'EXPERIMENTAL', 'label': 'DA-8031 dose 2', 'description': 'PO administration', 'interventionNames': ['Drug: DA-8031']}, {'type': 'EXPERIMENTAL', 'label': 'DA-8031 dose 3', 'description': 'PO administration', 'interventionNames': ['Drug: DA-8031']}], 'interventions': [{'name': 'DA-8031', 'type': 'DRUG', 'armGroupLabels': ['DA-8031 dose 1', 'DA-8031 dose 2', 'DA-8031 dose 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo of DA-8031, undistinguishable', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung Won Lee', 'role': 'CONTACT'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sung Won Lee', 'role': 'CONTACT', 'email': 'drswlee@skku.edu'}], 'overallOfficials': [{'name': 'Sae Woong Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital"}, {'name': 'Du Geon Moon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Guro Hospital'}, {'name': 'Nam-Cheol Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pusan National University Hospital'}, {'name': 'Jae-Seung Paick', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Tai-Young Ahn', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}, {'name': 'Sung Won Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}, {'name': 'Ki Hak Moon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yeongnam University Hospital'}, {'name': 'Kwangsung Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonnam National University Hospital'}, {'name': 'Jong Kwan Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonbuk National University Hospital'}, {'name': 'Dae Yul Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kangdong Sacred Heart Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}