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

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).

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Key information

Conditions

Herpes Zoster Blood-Borne Infections Communicable Diseases DNA Virus Infections Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Genital Diseases Glucose Metabolism Disorders HIV Infections Herpesviridae Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Urogenital Diseases Varicella Zoster Virus Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NeurogesX Investigational Site, Huntsville, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Capsaicin Dermal Patch

Drug

Sponsors and collaborators

Lead sponsor

NeurogesX

Industry

Registry information

Official study 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

Important dates

First posted: May 7, 2004
Registry last updated: Jan 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed