Clinical trial NCT00082316: Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herpes Zoster
Neuralgia
Pain
HIV Infections
Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Polyneuropathies
Keywords: Dermal assessment
Pain assessment
Diary
Analgesics
Capsaicin
Herpes zoster
Neuralgia
HIV Infections
Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Polyneuropathies
Complementary Therapies
Lead sponsor: NeurogesX
Sponsor class: INDUSTRY
First posted: 2004-05-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: NeurogesX Investigational Site
state: Alabama
city: Mobile
country: United States
facility: NeurogesX Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: NeurogesX Investigational Site
state: Arizona
city: Fountain Valley
country: United States
facility: NeurogesX Investigational Site
state: California
city: Los Gatos
country: United States
facility: NeurogesX Investigational Site
state: California
city: Denver
country: United States
facility: NeurogesX Investigational Site
state: Colorado
city: Clearwater
country: United States
facility: NeurogesX Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: NeurogesX Investigational Site
state: Florida
city: North Miami
country: United States
facility: NeurogesX Investigational Site
state: Florida
city: Plantation
country: United States
facility: NeurogesX Investigational Site
state: Florida
city: West Des Moines
country: United States
facility: NeurogesX Investigational Site
state: Iowa
city: Wellesley Hills
country: United States
facility: NeurogesX Investigational Site
state: Massachusetts
city: Saint Louis
country: United States
facility: NeurogesX Investigational Site
state: Missouri
city: Greensboro
country: United States
facility: NeurogesX Investigational Site
state: New Jersey
city: Duncansville
country: United States
facility: NeurogesX Investigational Site
state: Pennsylvania
city: San Antonio
country: United States
facility: NeurogesX Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: NeurogesX Investigational Site
state: Utah
Study officials:
References:
citation: 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):187-197. doi: 10.1016/j.diabres.2011.04.010. Epub 2011 May 25.