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

This study has been completed.
Information provided by:
NeurogesX Identifier:
First received: May 5, 2004
Last updated: January 3, 2008
Last verified: January 2008
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
HIV Infections
Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Drug: Capsaicin Dermal Patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: 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 NLM:

Further study details as provided by NeurogesX:


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier (NCT Number): Identifier: NCT00082316     History of Changes
Other Study ID Numbers: C111 
Study First Received: May 5, 2004
Last Updated: January 3, 2008
Health Authority: United States: Food and Drug Administration

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
Diabetic Neuropathies
HIV Infections
Herpes Zoster
Nervous System Diseases
Peripheral Nervous System Diseases
DNA Virus Infections
Diabetes Complications
Endocrine System Diseases
Glucose Metabolism Disorders
Herpesviridae Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Metabolic Diseases
Neurologic Manifestations
Neuromuscular Diseases
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Signs and Symptoms
Virus Diseases
Anesthetics, Local
Antipruritics processed this record on May 26, 2016