Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-24 @ 2:34 PM
Study NCT ID:
NCT00089557
Status:
TERMINATED
Last Update Posted:
2005-06-24
First Post:
2004-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label Extension Study of NGX-4010 for the Treatment of Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006562', 'term': 'Herpes Zoster'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D011115', 'term': 'Polyneuropathies'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'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'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'TERMINATED', 'statusVerifiedDate': '2004-09', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2004-08-06', 'studyFirstSubmitQcDate': '2004-08-06', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-08-09', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Dermal assessment', 'Pain assessment', 'Diary', 'Analgesics', 'Capsaicin', 'Herpes zoster', 'Neuralgia', 'Pain', 'HIV Infections', 'Peripheral Nervous System Diseases', 'Diabetic Neuropathies', 'Diabetes Mellitus', 'Polyneuropathies', 'Complementary Therapies'], 'conditions': ['Herpes Zoster', 'Neuralgia', 'Pain', 'HIV Infections', 'Peripheral Nervous System Diseases', 'Diabetic Neuropathies', 'Diabetes Mellitus', 'Polyneuropathies']}, 'descriptionModule': {'briefSummary': 'This study is an open-label, multicenter, extension study for subjects who completed NeurogesX Study C111 and received treatment with NGX-4010 (Capsaicin Patch) within 12 weeks (up to +7days) before entry into Study C114'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Eligibility Criteria:\n\n* Must have completed NeurogesX Study C111 and received treatment with NGX-4010 (Capsaicin Patch) within 12 weeks (up to +7 days) before entry into Study C114.\n* Demonstrated adherence to protocol requirements during Study C111, and willing and able to comply with protocol requirements for the duration of the study participation.\n* Must not have had any serious adverse experience since enrollment in Study C111, whether or not considered to be study drug-related.\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 (36 weeks).\n* Must not use topical pain medications on painful areas.\n* Must be at least 18 years old, not pregnant, and able to take care of self independently, with only occasional assistance if needed.\n* No history or current problem with substance abuse.'}, 'identificationModule': {'nctId': 'NCT00089557', 'briefTitle': 'An Open-Label Extension Study of NGX-4010 for the Treatment of Neuropathic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'NeurogesX'}, 'officialTitle': 'An Open-Label Extension Study of NGX-4010 for the Treatment of Neuropathic Pain', 'orgStudyIdInfo': {'id': 'C114'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Capsaicin Dermal Patch', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NeurogesX', 'class': 'INDUSTRY'}}}}