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Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT00082316
Recruitment Status : Completed
First Posted : May 7, 2004
Last Update Posted : January 11, 2008
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Herpes Zoster Neuralgia Pain HIV Infections Peripheral Nervous System Diseases Diabetic Neuropathies Diabetes Mellitus Polyneuropathies Drug: Capsaicin Dermal Patch Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
Drug Information available for: Capsaicin
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Eligibility Criteria:

  • Must have had for at least 3 months painful diabetic neuropathy, or postherpetic neuralgia, or painful HIV-associated neuropathy, with moderate to severe pain on average.
  • Must not have significant pain due to other causes (for example, arthritis).
  • Must have intact skin at the treatment area.
  • 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).
  • Must not use topical pain medications on painful areas.
  • Must be able to comply with study requirements such as completing daily pain diary and attending study visits and refrain from extensive travel during study participation.
  • Must be at least 18 years old, not pregnant, and able to take care of self independently, with only occasional assistance if needed.
  • No significant medical problems of the heart, kidneys, liver or lungs, or cancer.
  • No history or current problem with substance abuse.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082316

United States, Alabama
NeurogesX Investigational Site
Huntsville, Alabama, United States, 35801
NeurogesX Investigational Site
Mobile, Alabama, United States, 36608
United States, Arizona
NeurogesX Investigational Site
Phoenix, Arizona, United States, 85023
United States, California
NeurogesX Investigational Site
Fountain Valley, California, United States, 92708
NeurogesX Investigational Site
Los Gatos, California, United States, 95032
United States, Colorado
NeurogesX Investigational Site
Denver, Colorado, United States, 80209
United States, Florida
NeurogesX Investigational Site
Clearwater, Florida, United States, 33765
NeurogesX Investigational Site
New Port Richey, Florida, United States, 34652
NeurogesX Investigational Site
North Miami, Florida, United States, 33161
NeurogesX Investigational Site
Plantation, Florida, United States, 33324
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
Sponsors and Collaborators
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00082316     History of Changes
Other Study ID Numbers: C111
First Posted: May 7, 2004    Key Record Dates
Last Update Posted: January 11, 2008
Last Verified: January 2008

Keywords provided by NeurogesX:
Dermal assessment
Pain assessment
Herpes zoster
HIV Infections
Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Complementary Therapies

Additional relevant MeSH terms:
Diabetes Mellitus
HIV Infections
Diabetic Neuropathies
Nervous System Diseases
Herpes Zoster
Peripheral Nervous System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Herpesviridae Infections
DNA Virus Infections
Anesthetics, Local
Central Nervous System Depressants