Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT00797394
Status:
COMPLETED
Last Update Posted:
2011-04-13
First Post:
2008-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Natural Extract 2007RD01 Combined With Saw Palmetto in Benign Prostatic Hyperplasia Patients Compared to Saw Palmetto
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'lastUpdateSubmitDate': '2011-04-11', 'studyFirstSubmitDate': '2008-11-24', 'studyFirstSubmitQcDate': '2008-11-24', 'lastUpdatePostDateStruct': {'date': '2011-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute and relative (%) change in IPSS between baseline and end of study', 'timeFrame': '90 days ±7 days'}], 'secondaryOutcomes': [{'measure': 'Absolute and relative (%) change in IPSS between baseline and day 30 of follow-up', 'timeFrame': '30 days ±7 days'}, {'measure': 'Absolute and relative (%) change in peak urinary flow between baseline and after 30 or 90 days of follow-up', 'timeFrame': '30 days ±7 days , 90 days ±7 days'}, {'measure': 'Absolute and relative (%) change in post-void residual volume between baseline and after 30 or 90 days of follow-up', 'timeFrame': '30 days ±7 days , 90 days ±7 days'}, {'measure': 'Change in health related quality of life between baseline and after 30 or 90 days of follow-up', 'timeFrame': '30 days ±7 days , 90 days ±7 days'}, {'measure': 'Change in sexual function between baseline and after 30 or 90 days of follow-up', 'timeFrame': '30 days ±7 days , 90 days ±7 days'}]}, 'conditionsModule': {'keywords': ['prostate', 'dietary supplements', 'saw palmetto', 'canada'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the combination of 2007RD01, a natural extract, and saw palmetto lipidic extract, is more effective at treating lower urinary tract symptoms associated with benign prostatic hyperplasia than saw palmetto lipidic extract alone.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must be an adult man aged between 50 and 75\n* Patient must have Benign Prostatic Hyperplasia symptoms\n\nExclusion Criteria:\n\n* Patient has a malfunction of the urinary tract, is suffering from acute urinary retention, or is suffering from prostate cancer or urinary tract infection\n* Patient has been subjected to surgery of the prostate, bladder or urethra\n* Patient has taken a 5-alpha-reductase inhibitor in the 6-month period preceding screening\n* Patient has taken an alpha-blocker in the 2-week period preceding screening'}, 'identificationModule': {'nctId': 'NCT00797394', 'briefTitle': 'Efficacy of Natural Extract 2007RD01 Combined With Saw Palmetto in Benign Prostatic Hyperplasia Patients Compared to Saw Palmetto', 'organization': {'class': 'INDUSTRY', 'fullName': 'innoVactiv Inc.'}, 'orgStudyIdInfo': {'id': '2007-RD-01-CLN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treated', 'interventionNames': ['Dietary Supplement: Combination of 2007RD01 and saw palmetto lipidic extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Dietary Supplement: Saw palmetto lipidic extract']}], 'interventions': [{'name': 'Combination of 2007RD01 and saw palmetto lipidic extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral administration of one capsule containing a combination of 250 mg of 2007RD01 (a natural extract) and 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals', 'armGroupLabels': ['Treated']}, {'name': 'Saw palmetto lipidic extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral administration of one capsule of 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J2G 8Z9', 'city': 'Granby', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Recherches Cliniques Theradev', 'geoPoint': {'lat': 45.40008, 'lon': -72.73243}}, {'zip': 'J4V 2H3', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Urology South Shore Research', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H2X 1N8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Les Urologues Associés du CHUM', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1S 2L6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': "Clinique d'urologie Berger", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'innoVactiv Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Jocelyn Bérubé / Scientific Director, Health & Nutrition', 'oldOrganization': 'innoVactiv inc.'}}}}