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Sponsored by: |
NeurogesX |
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Information provided by: | NeurogesX |
ClinicalTrials.gov Identifier: | NCT00082316 |
This study is a randomized, open-label multi-center evaluation of the tolerability of treatment with NGX-4010 in conjunction with pre-patch topical application of one of three 4% lidocaine-based local anesthetic products. Eligible subjects will have moderate to severe neuropathic pain secondary to painful diabetic neuropathy (PDN), postherpetic neuralgia (PHN) or HIV-associated neuropathy (HIV-AN), with average numeric pain rating scale (NPRS) scores during screening of 3 to 8 (inclusive).
Condition | Intervention | Phase |
---|---|---|
Herpes Zoster Neuralgia Pain HIV Infections Peripheral Nervous System Diseases Diabetic Neuropathies Diabetes Mellitus Polyneuropathies |
Drug: Capsaicin Dermal Patch |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label Study of the Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Eligibility Criteria:
United States, Alabama | |
NeurogesX Investigational Site | |
Mobile, Alabama, United States, 36608 | |
NeurogesX Investigational Site | |
Huntsville, Alabama, United States, 35801 | |
United States, Arizona | |
NeurogesX Investigational Site | |
Phoenix, Arizona, United States, 85023 | |
United States, California | |
NeurogesX Investigational Site | |
Los Gatos, California, United States, 95032 | |
NeurogesX Investigational Site | |
Fountain Valley, California, United States, 92708 | |
United States, Colorado | |
NeurogesX Investigational Site | |
Denver, Colorado, United States, 80209 | |
United States, Florida | |
NeurogesX Investigational Site | |
New Port Richey, Florida, United States, 34652 | |
NeurogesX Investigational Site | |
Plantation, Florida, United States, 33324 | |
NeurogesX Investigational Site | |
North Miami, Florida, United States, 33161 | |
NeurogesX Investigational Site | |
Clearwater, Florida, United States, 33765 | |
United States, Iowa | |
NeurogesX Investigational Site | |
West Des Moines, Iowa, United States, 50265 | |
United States, Massachusetts | |
NeurogesX Investigational Site | |
Wellesley Hills, Massachusetts, United States, 02481-2106 | |
United States, Missouri | |
NeurogesX Investigational Site | |
Saint Louis, Missouri, United States, 63108 | |
United States, New Jersey | |
NeurogesX Investigational Site | |
Greensboro, New Jersey, United States, 27408 | |
United States, Pennsylvania | |
NeurogesX Investigational Site | |
Duncansville, Pennsylvania, United States, 16635 | |
United States, Texas | |
NeurogesX Investigational Site | |
San Antonio, Texas, United States, 78229 | |
United States, Utah | |
NeurogesX Investigational Site | |
Salt Lake City, Utah, United States, 84106 |
Study ID Numbers: | C111 |
Study First Received: | May 5, 2004 |
Last Updated: | January 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00082316 |
Health Authority: | United States: Food and Drug Administration |
Dermal assessment Pain assessment Diary Analgesics Capsaicin Herpes zoster Neuralgia |
HIV Infections Peripheral Nervous System Diseases Diabetic Neuropathies Diabetes Mellitus Polyneuropathies Complementary Therapies |
Sexually Transmitted Diseases, Viral Pain Signs and Symptoms Neuromuscular Diseases Retroviridae Infections Diabetes Complications Herpes Zoster Metabolic Diseases Neuralgia Diabetic Neuropathies Acquired Immunodeficiency Syndrome Diabetes Mellitus Polyneuropathies |
Endocrine System Diseases Capsaicin Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases HIV Infections Peripheral Nervous System Diseases Sexually Transmitted Diseases Neurologic Manifestations DNA Virus Infections Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Nervous System Diseases Physiological Effects of Drugs Infection Pharmacologic Actions |
Sensory System Agents Therapeutic Uses Lentivirus Infections Antipruritics Peripheral Nervous System Agents Dermatologic Agents |