Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-30 @ 1:05 AM
Study NCT ID:
NCT01222650
Status:
COMPLETED
Last Update Posted:
2011-07-04
First Post:
2010-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study of KSO-0400 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': 'C095285', 'term': 'silodosin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'lastUpdateSubmitDate': '2011-06-30', 'studyFirstSubmitDate': '2010-10-15', 'studyFirstSubmitQcDate': '2010-10-15', 'lastUpdatePostDateStruct': {'date': '2011-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in I-PSS Total Score from baseline', 'timeFrame': 'Baseline and 12 weeks (LOCF)'}], 'secondaryOutcomes': [{'measure': 'Change in I-PSS Sub-score from baseline', 'timeFrame': 'Baseline and 12 weeks (LOCF)'}, {'measure': 'Change in QOL Score from baseline', 'timeFrame': 'Baseline and 12 weeks (LOCF)'}, {'measure': 'Change in Qmax (maximum urinary flow rate) from baseline', 'timeFrame': 'Baseline and 12 weeks (LOCF)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Benign Prostatic Hyperplasia', 'I-PSS', 'α1A-AR antagonist'], 'conditions': ['Benign Prostatic Hyperplasia (BPH)']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy and safety of KSO-0400 compared to placebo for the treatment of LUTS caused by BPH.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BPH patients with LUTS\n\nExclusion Criteria:\n\n* Patients with a history of prostatectomy, intrapelvic radiation therapy, thermotherapy of prostate or prostatic hyperthermia\n* Patients with prostate cancer or suspected prostate cancer\n* Patients who have any clinically relevant cardiovascular, hepatic or renal disorder'}, 'identificationModule': {'nctId': 'NCT01222650', 'briefTitle': 'A Comparative Study of KSO-0400 in BPH Patients With LUTS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kissei Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multicentre Study of KSO-0400 in BPH Patients With LUTS', 'orgStudyIdInfo': {'id': 'KSO1201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KSO-0400 Low Dose', 'interventionNames': ['Drug: KSO-0400']}, {'type': 'EXPERIMENTAL', 'label': 'KSO-0400 High Dose', 'interventionNames': ['Drug: KSO-0400']}, {'type': 'EXPERIMENTAL', 'label': 'Silodosin', 'interventionNames': ['Drug: Silodosin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'KSO-0400', 'type': 'DRUG', 'armGroupLabels': ['KSO-0400 Low Dose']}, {'name': 'KSO-0400', 'type': 'DRUG', 'armGroupLabels': ['KSO-0400 High Dose']}, {'name': 'Silodosin', 'type': 'DRUG', 'armGroupLabels': ['Silodosin']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kanto Region', 'country': 'Japan', 'facility': 'Japan'}], 'overallOfficials': [{'name': 'Katsumi Hontani', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Development Dept.,Kissei Pharmaceutical Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kissei Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}}}}