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

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

U.S. FDA Resources

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082316

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

Sponsors and Collaborators

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

Keywords provided by NeurogesX:

Dermal assessment

Pain assessment

Diary

Analgesics

Capsaicin

Herpes zoster

Neuralgia

HIV Infections

Peripheral Nervous System Diseases

Diabetic Neuropathies

Diabetes Mellitus

Polyneuropathies

Complementary Therapies

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral

Pain

Signs and Symptoms

Neuromuscular Diseases

Retroviridae Infections

Diabetes Complications

Herpes Zoster

Metabolic Diseases

Neuralgia

Diabetic Neuropathies

Acquired Immunodeficiency Syndrome

Diabetes Mellitus

Polyneuropathies

Endocrine System Diseases

Capsaicin

Immunologic Deficiency Syndromes

Herpesviridae Infections

Virus Diseases

HIV Infections

Peripheral Nervous System Diseases

Sexually Transmitted Diseases

Neurologic Manifestations

DNA Virus Infections

Endocrinopathy

Glucose Metabolism Disorders

Metabolic disorder

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Nervous System Diseases

Physiological Effects of Drugs

Infection

Pharmacologic Actions

Sensory System Agents

Therapeutic Uses

Lentivirus Infections

Antipruritics

Peripheral Nervous System Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on September 04, 2008

Sponsored by:	NeurogesX
Information provided by:	NeurogesX
ClinicalTrials.gov Identifier:	NCT00082316