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

Sponsor:	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

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus complement factor I deficiency

MedlinePlus related topics: Diabetic Nerve Problems HIV/AIDS Neurologic Diseases Peripheral Nerve Disorders Shingles

Drug Information available for: Capsaicin

U.S. FDA Resources

Further study details as provided by NeurogesX:

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
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

NeurogesX

More Information

No publications provided by NeurogesX

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Webster LR, Peppin JF, Murphy FT, Lu B, Tobias JK, Vanhove GF. Efficacy, safety, and tolerability of NGX-4010, capsaicin 8% patch, in an open-label study of patients with peripheral neuropathic pain. Diabetes Res Clin Pract. 2011 Aug;93(2):187-97. Epub 2011 May 25.

ClinicalTrials.gov 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
Diary
Analgesics
Capsaicin
Herpes zoster
Neuralgia

HIV Infections
Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Polyneuropathies
Complementary Therapies

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Diabetes Mellitus
Diabetic Neuropathies
Herpes Zoster
Nervous System Diseases
Neuralgia
Peripheral Nervous System Diseases
Polyneuropathies
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases

Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Diabetes Complications
Herpesviridae Infections
DNA Virus Infections
Pain
Neurologic Manifestations
Signs and Symptoms
Anesthetics, Local
Anesthetics

ClinicalTrials.gov processed this record on February 12, 2012