Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-28 @ 1:36 AM
Study NCT ID:
NCT00759135
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2008-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)
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': 'C000654327', 'term': 'fexapotide'}, {'id': 'D018120', 'term': 'Finasteride'}], 'ancestors': [{'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001378', 'term': 'Azasteroids'}, {'id': 'D013260', 'term': 'Steroids, Heterocyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'dispFirstSubmitDate': '2010-08-30', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-12', 'studyFirstSubmitDate': '2008-09-23', 'dispFirstSubmitQcDate': '2010-08-30', 'studyFirstSubmitQcDate': '2008-09-24', 'dispFirstPostDateStruct': {'date': '2010-09-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in BPH Symptom Score (AUA SI)', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'Change in Prostate Volume', 'timeFrame': '90 days'}, {'measure': 'Change in Qmax', 'timeFrame': '90 days'}, {'measure': 'Change in BPH Symptom Score (AUA SI)', 'timeFrame': '30 days'}, {'measure': 'Change in BPH Symptom Score (AUA SI)', 'timeFrame': '180 days'}, {'measure': 'Number of Participants with Adverse Events, duration and severity of Adverse Events and relation, if any, to drug', 'timeFrame': '180 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Benign Prostatic Hyperplasia', 'BPH', 'Enlarged Prostate'], 'conditions': ['Benign Prostatic Hyperplasia (BPH)', 'Enlarged Prostate']}, 'descriptionModule': {'briefSummary': 'This completed study evaluated the safety and efficacy of two dose levels of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) versus finasteride.', 'detailedDescription': 'Subjects randomized to NX-1207 were blinded as to the dose level of NX-1207 they received.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Documented history of BPH for at least 1 year\n2. AUA SI ≥ 15\n3. Prostate Volume ≥ 30 mL ≤ 70 mL\n4. Qmax \\< 15 mL/sec\n\nExclusion Criteria:\n\n1. History of illness or condition that may interfere with study or endanger subject\n2. Use of prescribed medications that may interfere with study or endanger subject\n3. Presence of a median lobe of the prostate\n4. Surgery or MIST in the previous 12 months for treatment of BPH\n5. Post-void residual urine volume \\> 350 mL\n6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out for PSA ≥ 4 ng/mL'}, 'identificationModule': {'nctId': 'NCT00759135', 'briefTitle': 'Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nymox Corporation'}, 'officialTitle': 'Phase 2 Multicenter Randomized Two Dose Level and Non-Inferiority Clinical Evaluation of Transrectal Administration of NX-1207 for the Treatment of BPH', 'orgStudyIdInfo': {'id': 'NX02-0016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Single therapeutic dose of 2.5 mg NX-1207', 'interventionNames': ['Drug: 2.5 mg NX-1207']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Single low dose of 0.125 mg NX-1207 for dose-response evaluation', 'interventionNames': ['Drug: 0.125 mg NX-1207']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': '5.0 mg finasteride q.d.', 'interventionNames': ['Drug: finasteride']}], 'interventions': [{'name': '2.5 mg NX-1207', 'type': 'DRUG', 'description': 'Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207', 'armGroupLabels': ['1']}, {'name': '0.125 mg NX-1207', 'type': 'DRUG', 'description': 'Low dose; single intraprostatic injection of 0.125 mg NX-1207', 'armGroupLabels': ['2']}, {'name': 'finasteride', 'type': 'DRUG', 'description': 'Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days)', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Atherton', 'state': 'California', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 37.46133, 'lon': -122.19774}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'New Britain', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 41.66121, 'lon': -72.77954}}, {'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'city': 'Greenwood', 'state': 'Indiana', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 39.61366, 'lon': -86.10665}}, {'city': 'Jeffersonville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 38.27757, 'lon': -85.73718}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'city': 'Garden City', 'state': 'New York', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 40.72677, 'lon': -73.6343}}, {'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'city': 'Brownsville', 'state': 'Texas', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 25.90175, 'lon': -97.49748}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Nymox Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nymox Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}