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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00082316
• Other study ID #: C111
• Status: Completed
• Phase: Phase 2
• First received: May 5, 2004
• Last updated: January 3, 2008

Study information

• Verified date: January 2008
• Source: NeurogesX
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Neuropathies
• Herpes Zoster
• HIV Infections
• Nervous System Diseases
• Neuralgia
• Pain
• Peripheral Nervous System Diseases
• Polyneuropathies

Intervention

Drug:
• Capsaicin Dermal Patch

Locations

Country	Name	City	State
United States	NeurogesX Investigational Site	Clearwater	Florida
United States	NeurogesX Investigational Site	Denver	Colorado
United States	NeurogesX Investigational Site	Duncansville	Pennsylvania
United States	NeurogesX Investigational Site	Fountain Valley	California
United States	NeurogesX Investigational Site	Greensboro	New Jersey
United States	NeurogesX Investigational Site	Huntsville	Alabama
United States	NeurogesX Investigational Site	Los Gatos	California
United States	NeurogesX Investigational Site	Mobile	Alabama
United States	NeurogesX Investigational Site	New Port Richey	Florida
United States	NeurogesX Investigational Site	North Miami	Florida
United States	NeurogesX Investigational Site	Phoenix	Arizona
United States	NeurogesX Investigational Site	Plantation	Florida
United States	NeurogesX Investigational Site	Saint Louis	Missouri
United States	NeurogesX Investigational Site	Salt Lake City	Utah
United States	NeurogesX Investigational Site	San Antonio	Texas
United States	NeurogesX Investigational Site	Wellesley Hills	Massachusetts
United States	NeurogesX Investigational Site	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
NeurogesX

Country where clinical trial is conducted

United States,