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| Sponsor: | NeurogesX |
|---|---|
| Information provided by: | NeurogesX |
| ClinicalTrials.gov Identifier: | NCT00082316 |
Purpose
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Key Eligibility Criteria:
Contacts and Locations| 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 | |
More Information
| Study ID Numbers: | C111 |
| Study First Received: | May 5, 2004 |
| Last Updated: | January 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00082316 History of Changes |
| 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 |
|
Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Physiological Effects of Drugs Anesthetics Pain Infection Signs and Symptoms Neuromuscular Diseases Sensory System Agents Therapeutic Uses Antipruritics Dermatologic Agents Retroviridae Infections Diabetes Complications |
Herpes Zoster RNA Virus Infections Metabolic Diseases Neuralgia Diabetic Neuropathies Immune System Diseases Nervous System Diseases Acquired Immunodeficiency Syndrome Polyneuropathies Diabetes Mellitus Central Nervous System Depressants Endocrine System Diseases Capsaicin Pharmacologic Actions Anesthetics, Local |