Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT00359905
Status:
COMPLETED
Last Update Posted:
2009-02-19
First Post:
2006-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH
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'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-18', 'studyFirstSubmitDate': '2006-08-02', 'studyFirstSubmitQcDate': '2006-08-02', 'lastUpdatePostDateStruct': {'date': '2009-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in baseline total score on the International Prostate Symptom Score', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in baseline obstructive subscore of the International Prostate Symptom Score;', 'timeFrame': '12 weeks'}, {'measure': 'change in baseline irritative subscore of the International Prostate Symptom Score;', 'timeFrame': '12 weeks'}, {'measure': 'change in baseline maximum urine flow rate;', 'timeFrame': '12 weeks'}, {'measure': 'safety', 'timeFrame': '52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Benign prostatic hyperplasia', 'alpha-blockers'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '25712312', 'type': 'DERIVED', 'citation': 'Osman NI, Chapple CR, Tammela TL, Eisenhardt A, Oelke M. Open-label, 9-month extension study investigating the uro-selective alpha-blocker silodosin in men with LUTS associated with BPH. World J Urol. 2015 May;33(5):697-706. doi: 10.1007/s00345-015-1519-2. Epub 2015 Feb 25.'}, {'pmid': '21109344', 'type': 'DERIVED', 'citation': 'Chapple CR, Montorsi F, Tammela TL, Wirth M, Koldewijn E, Fernandez Fernandez E; European Silodosin Study Group. Silodosin therapy for lower urinary tract symptoms in men with suspected benign prostatic hyperplasia: results of an international, randomized, double-blind, placebo- and active-controlled clinical trial performed in Europe. Eur Urol. 2011 Mar;59(3):342-52. doi: 10.1016/j.eururo.2010.10.046. Epub 2010 Nov 10.'}]}, 'descriptionModule': {'briefSummary': 'A new drug for the treatment of benign prostatic hyperplasia is compared with placebo and tamsulosin (a drug belonging to the same therapeutic class) for to determine if it is safe and effective (the first phase of the study lasts approximately 18 weeks) and then is used for another 9 months to determine its long-term safety.', 'detailedDescription': 'This is a multi-centre, double-blind, placebo and active controlled, parallel 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia, followed by a 9 month open-label phase. The following procedures are used: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, quality of life and compliance. 93 centres in 11 European countries (Finland, France, Germany, Italy, Netherlands, Poland, Romania, Russia, Spain, Ukraine, UK) will be involved'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males in good general health and at least 50 years of age, with symptoms of moderate to severe Benign Prostatic Hyperplasia\n\nExclusion Criteria:\n\n* Medical conditions that would confound the efficacy evaluation\n* Medical conditions in which it would be unsafe to use an alpha-blocker\n* Use of concomitant drugs that would confound the efficacy evaluation\n* Use of concomitant drugs that would be unsafe with this alpha-blocker'}, 'identificationModule': {'nctId': 'NCT00359905', 'briefTitle': 'Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH', 'organization': {'class': 'INDUSTRY', 'fullName': 'RECORDATI GROUP'}, 'officialTitle': 'Evaluation of the Efficacy and Safety of Silodosin vs. Tamsulosin and Placebo in the Treatment of the Signs and Symptoms of BPH. Multicentre, Randomised, Double-Blind, Controlled Trial With an Optional Long-Term, Open-Label Extension Phase.', 'orgStudyIdInfo': {'id': 'KMD3213-IT-CL 0215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Silodosin', 'interventionNames': ['Drug: Silodosin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tamsulosin', 'interventionNames': ['Drug: Tamsulosin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Silodosin', 'type': 'DRUG', 'otherNames': ['KMD3213'], 'description': '8 mg daily for 12 weeks', 'armGroupLabels': ['Silodosin']}, {'name': 'Tamsulosin', 'type': 'DRUG', 'otherNames': ['Omnic'], 'description': '0.4 mg daily for 12 weeks', 'armGroupLabels': ['Tamsulosin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'once daily for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S10 2JF', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Christopher Re Chapple, BSc MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RECORDATI GROUP', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Senior Clinical Project Leader', 'oldOrganization': 'Recordati Industria Chimica e Farmaceutica S.p.A.'}}}}