Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-22 @ 5:22 PM
Study NCT ID:
NCT01846793
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2013-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D001748', 'term': 'Urinary Bladder Neck Obstruction'}], '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'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014524', 'term': 'Urethral Obstruction'}, {'id': 'D014522', 'term': 'Urethral Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000654327', 'term': 'fexapotide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'dispFirstSubmitDate': '2017-03-09', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2013-05-01', 'dispFirstSubmitQcDate': '2017-03-09', 'studyFirstSubmitQcDate': '2013-05-01', 'dispFirstPostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '180 days', 'description': 'Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).'}], 'secondaryOutcomes': [{'measure': 'Symptomatic Improvement', 'timeFrame': '90 days', 'description': 'Symptomatic improvement as measured by the change in American Urological Association (AUA) Symptom Index from baseline at 90 days. The AUA Symptom Index is a standardized questionnaire that uses seven questions relating to associated BPH symptoms to provide an assessment of symptom severity on a scale from 0 (no symptoms) to 35 (most severe).'}, {'measure': 'Prostate Volume Change', 'timeFrame': '90 days', 'description': 'Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography'}, {'measure': 'Change in Urinary Peak Flow', 'timeFrame': '90 days.', 'description': 'Change in Urinary Peak Flow (Qmax) from baseline to 90 days as determined by urinary flow-rate recording (uroflowmetry).'}, {'measure': 'Symptomatic Improvement', 'timeFrame': '180 days', 'description': 'Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Benign prostatic hyperplasia', 'BPH', 'Lower urinary tract symptoms', 'LUTS', 'LUTS secondary to BPH', 'LUTS/BPH', 'Benign prostatic obstruction (BPO)', 'BPO', 'Bladder outlet obstruction', 'BOO'], 'conditions': ['Benign Prostatic Hyperplasia', 'BPH', 'Lower Urinary Tract Symptoms (LUTS)', 'LUTS']}, 'descriptionModule': {'briefSummary': 'This study is designed to demonstrate the safety and efficacy of a second transrectal intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH) who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be male aged 45 or older.\n* Sign an informed consent form.\n* Be in good health.\n* Received NX-1207 in a previous completed study (other than NX02-0020) or received NX-1207 or placebo in a concurrent U.S. study (NX02-0017 and NX02-0018) and completed their V10 (365 day) visit.\n* Have Prostate Gland Volume ≥ 25 mL (25 g).\n\nExclusion Criteria:\n\n* Surgery or minimally invasive surgical therapy (MIST) for treatment of BPH after first NX-1207 injection\n* Post-void residual urine volume \\> 200 mL\n* Presence of a symptomatic median lobe of the prostate\n* History of use of self-catheterization for urinary retention.\n* Urinary retention in the previous 12 months.\n* Prostatitis\n* Urinary tract infection more than once in the past 12 months\n* Prostate or bladder cancer.\n* Prostate-Specific Antigen (PSA) ≥ 10 ng/mL\n* Poorly controlled diabetes\n* History or evidence of illness or condition that may interfere with study or endanger subject\n* Participation in a study of any investigational drug (other than NX-1207) or investigational device within the previous 90 days\n* Use of specific prescribed medications that may interfere with study or endanger subject'}, 'identificationModule': {'nctId': 'NCT01846793', 'briefTitle': 'Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nymox Corporation'}, 'officialTitle': 'Phase 3 Multicenter Prospective Open Label Clinical Safety Evaluation of Re-Injection of NX-1207 for the Treatment of BPH: Two Doses 1-8 Years Apart', 'orgStudyIdInfo': {'id': 'NX02-0022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open Label Injection of NX-1207', 'description': 'Intraprostatic injection of 2.5 mg NX-1207', 'interventionNames': ['Drug: NX-1207']}], 'interventions': [{'name': 'NX-1207', 'type': 'DRUG', 'description': '2.5 mg NX-1207 in 10 mL saline vehicle', 'armGroupLabels': ['Open Label Injection of NX-1207']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92653', 'city': 'Laguna Beach', 'state': 'California', 'country': 'United States', 'facility': 'For information concerning this clinical site, please contact Nymox at 800-936-9669.', 'geoPoint': {'lat': 33.54225, 'lon': -117.78311}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'For information concerning this clinical site, please contact Nymox at 800-936-9669.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'For information concerning this clinical site, please contact Nymox at 800-936-9669.', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'For information concerning this clinical site, please contact Nymox at 800-936-9669.', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'For information concerning this clinical site, please contact Nymox at 800-936-9669.', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '47130', 'city': 'Jeffersonville', 'state': 'Indiana', 'country': 'United States', 'facility': 'For information concerning this clinical site, please contact Nymox at 800-936-9669.', 'geoPoint': {'lat': 38.27757, 'lon': -85.73718}}, {'zip': '71106', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'For information concerning this clinical site, please contact Nymox at 800-936-9669.', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'For information concerning this clinical site, please contact Nymox at 800-936-9669.', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'For information concerning this clinical site, please contact Nymox at 800-936-9669.', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21061', 'city': 'Glen Burnie', 'state': 'Maryland', 'country': 'United States', 'facility': 'For information concerning this clinical site, please contact Nymox at 800-936-9669.', 'geoPoint': {'lat': 39.16261, 'lon': -76.62469}}, {'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'For information concerning this clinical site, please contact Nymox at 800-936-9669.', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '59808', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'For information concerning this clinical site, please contact Nymox at 800-936-9669.', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '08724', 'city': 'Brick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'For information concerning this clinical site, please contact Nymox at 800-936-9669.', 'geoPoint': {'lat': 40.05928, 'lon': -74.13708}}, {'zip': '11530', 'city': 'Garden City', 'state': 'New York', 'country': 'United States', 'facility': 'For information concerning this clinical site, please contact Nymox at 800-936-9669.', 'geoPoint': {'lat': 40.72677, 'lon': -73.6343}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'For information concerning this clinical site, please contact Nymox at 800-936-9669.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'For information concerning this clinical site, please contact Nymox at 800-936-9669.', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '75010', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'For information concerning this clinical site, please contact Nymox at 800-936-9669.', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nymox Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}