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

Sponsor

NeurogesX (Industry)

Overall Status

Completed

CT.gov ID

NCT00082316

Collaborator

(none)

Locations

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Herpes Zoster Neuralgia Pain HIV Infections Peripheral Nervous System Diseases Diabetic Neuropathies Diabetes Mellitus Polyneuropathies	Drug: Capsaicin Dermal Patch	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

None (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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	NeurogesX Investigational Site	Huntsville	Alabama	United States	35801
2	NeurogesX Investigational Site	Mobile	Alabama	United States	36608
3	NeurogesX Investigational Site	Phoenix	Arizona	United States	85023
4	NeurogesX Investigational Site	Fountain Valley	California	United States	92708
5	NeurogesX Investigational Site	Los Gatos	California	United States	95032
6	NeurogesX Investigational Site	Denver	Colorado	United States	80209
7	NeurogesX Investigational Site	Clearwater	Florida	United States	33765
8	NeurogesX Investigational Site	New Port Richey	Florida	United States	34652
9	NeurogesX Investigational Site	North Miami	Florida	United States	33161
10	NeurogesX Investigational Site	Plantation	Florida	United States	33324
11	NeurogesX Investigational Site	West Des Moines	Iowa	United States	50265
12	NeurogesX Investigational Site	Wellesley Hills	Massachusetts	United States	02481-2106
13	NeurogesX Investigational Site	Saint Louis	Missouri	United States	63108
14	NeurogesX Investigational Site	Greensboro	New Jersey	United States	27408
15	NeurogesX Investigational Site	Duncansville	Pennsylvania	United States	16635
16	NeurogesX Investigational Site	San Antonio	Texas	United States	78229
17	NeurogesX Investigational Site	Salt Lake City	Utah	United States	84106