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| Sponsored by: |
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 |
| MedlinePlus related topics: | AIDS Anesthesia Diabetes Diabetic Nerve Problems Neurologic Diseases Peripheral Nerve Disorders Shingles |
| ChemIDplus related topics: | Capsaicin |
| 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 | |||||
| NeurogesX |
More Information
| Study ID Numbers: | C111 |
| First Received: | May 5, 2004 |
| Last Updated: | January 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00082316 |
| Health Authority: | United States: Food and Drug Administration |
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