Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-27 @ 9:31 PM
Study NCT ID:
NCT00085761
Status:
TERMINATED
Last Update Posted:
2008-03-06
First Post:
2004-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'whyStopped': 'Terminated in view of the C107 findings demonstrating efficacy at doses of 90 and 30 minutes', 'overallStatus': 'TERMINATED', 'statusVerifiedDate': '2008-03', 'lastUpdateSubmitDate': '2008-03-04', 'studyFirstSubmitDate': '2004-06-14', 'studyFirstSubmitQcDate': '2004-06-16', 'lastUpdatePostDateStruct': {'date': '2008-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-06-17', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Dermal assessment', 'Pain measurement', 'Diary', 'Neuropathy', 'Analgesics/*therapeutic use', 'Capsaicin/*administration & dosage/adverse effects', 'HIV Infections/*complications/*drug therapy', 'Pain', 'Complementary Therapies'], 'conditions': ['HIV Infections', 'Peripheral Nervous System Diseases', 'Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is safe, tolerable and effective in treating painful HIV-associated neuropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Eligibility Criteria:\n\n* Must have had HIV-associated neuropathy for at least 2 months, with moderate to severe pain in both feet.\n* Must not have significant pain in feet due to other causes (for example, arthritis).\n* Must have intact skin at the treatment area.\n* Must be prepared to remain on the same pain medications at the same doses as before the study for the entire duration of the study (12 weeks).\n* Must not use topical pain medications for HIV-associated neuropathy.\n* Must be able to comply with study requirements such as completing daily pain diary and attending study visits.\n* Must be at least 18 years old, not pregnant, and be able to take care of self independently, with only occasional assistance if needed.\n* No significant medical problems of the heart, kidneys, liver or lungs, or cancer.\n* No history or current problem with substance abuse.'}, 'identificationModule': {'nctId': 'NCT00085761', 'briefTitle': 'Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'NeurogesX'}, 'officialTitle': 'An International, Multicenter, Randomized, Double-Blind, 12-Week Controlled Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy', 'orgStudyIdInfo': {'id': 'C112'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Capsaicin Dermal Patch', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'NeurogesX Investigational Site', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '22003', 'city': 'Annandale', 'state': 'Virginia', 'country': 'United States', 'facility': 'NeurogesX Investigational Site', 'geoPoint': {'lat': 38.83039, 'lon': -77.19637}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NeurogesX', 'class': 'INDUSTRY'}}}}