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

Primary Purpose

Herpes Zoster, Neuralgia, Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Capsaicin Dermal Patch
Sponsored by
NeurogesX
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Zoster focused on measuring Dermal assessment, Pain assessment, Diary, Analgesics, Capsaicin, Herpes zoster, Neuralgia, HIV Infections, Peripheral Nervous System Diseases, Diabetic Neuropathies, Diabetes Mellitus, Polyneuropathies, Complementary Therapies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site
  • NeurogesX Investigational Site

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 5, 2004
Last Updated
January 3, 2008
Sponsor
NeurogesX
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1. Study Identification

Unique Protocol Identification Number
NCT00082316
Brief Title
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

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
NeurogesX

4. Oversight

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Capsaicin Dermal Patch

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
NeurogesX Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
NeurogesX Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
NeurogesX Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
NeurogesX Investigational Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
NeurogesX Investigational Site
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
NeurogesX Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
NeurogesX Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
NeurogesX Investigational Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
NeurogesX Investigational Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
NeurogesX Investigational Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
NeurogesX Investigational Site
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
NeurogesX Investigational Site
City
Wellesley Hills
State/Province
Massachusetts
ZIP/Postal Code
02481-2106
Country
United States
Facility Name
NeurogesX Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
NeurogesX Investigational Site
City
Greensboro
State/Province
New Jersey
ZIP/Postal Code
27408
Country
United States
Facility Name
NeurogesX Investigational Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
NeurogesX Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
NeurogesX Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21612836
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.
Results Reference
derived

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

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