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NGX-4010 for the Treatment of Postherpetic Neuralgia

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 measurement, Diary, Shingles, Neuropathy, Analgesics/*therapeutic use, Capsaicin/*administration & dosage/adverse effects, Herpes Zoster/*complications/drug therapy, Neuralgia/*drug therapy/etiology, Pain, Peripheral Nervous System Diseases/*complications

Eligibility Criteria

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

Key Eligibility Criteria: Must be diagnosed with PHN and be at least 6 months after crusting of the skin vesicles, with moderate to severe pain. Must not have significant pain due to causes other than PHN (for example, arthritis). Painful areas should not be located on the face, above the hairline of the scalp, and/or in proximity to mucous membranes. Must have intact and unbroken 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 (1-year). Must not have any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of pain. Must not use topical pain medications for PHN. Must be able to comply with study requirements such as completing a daily pain diary, attending study visits and refraining from extensive travel during study participation. 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
  • 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
June 3, 2003
Last Updated
March 4, 2008
Sponsor
NeurogesX
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1. Study Identification

Unique Protocol Identification Number
NCT00061776
Brief Title
NGX-4010 for the Treatment of Postherpetic Neuralgia
Official Title
A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
Study Type
Interventional

2. Study Status

Record Verification Date
March 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
The purpose of the study is determine if an investigational drug, NGX-4010 (high-concentration capsaicin dermal patches) is effective in treating pain associated with post-herpetic neuralgia (PHN).
Detailed Description
Participants will be randomly assigned to receive initial treatment according to one of three doses (application durations), and will receive either NGX-4010 patch (high-concentration capsaicin) or matching control (low-concentration capsaicin). Participants who complete the study evaluations for 12 weeks will have the option of receiving up to 3 additional open-label re-treatments over 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster, Neuralgia, Pain, Peripheral Nervous System Diseases, Shingles
Keywords
Dermal assessment, Pain measurement, Diary, Shingles, Neuropathy, Analgesics/*therapeutic use, Capsaicin/*administration & dosage/adverse effects, Herpes Zoster/*complications/drug therapy, Neuralgia/*drug therapy/etiology, Pain, Peripheral Nervous System Diseases/*complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Masking
Double
Allocation
Randomized
Enrollment
300 (false)

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 be diagnosed with PHN and be at least 6 months after crusting of the skin vesicles, with moderate to severe pain. Must not have significant pain due to causes other than PHN (for example, arthritis). Painful areas should not be located on the face, above the hairline of the scalp, and/or in proximity to mucous membranes. Must have intact and unbroken 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 (1-year). Must not have any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of pain. Must not use topical pain medications for PHN. Must be able to comply with study requirements such as completing a daily pain diary, attending study visits and refraining from extensive travel during study participation. 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
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
NeurogesX Investigational Site
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
NeurogesX Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
NeurogesX Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
NeurogesX Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
NeurogesX Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
NeurogesX Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
NeurogesX Investigational Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
NeurogesX Investigational Site
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
NeurogesX Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
NeurogesX Investigational Site
City
Palm Beach Garden
State/Province
Florida
ZIP/Postal Code
33410
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
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
NeurogesX Investigational Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States
Facility Name
NeurogesX Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
NeurogesX Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
NeurogesX Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
NeurogesX Investigational Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
NeurogesX Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
NeurogesX Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
NeurogesX Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
NeurogesX Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
93104
Country
United States
Facility Name
NeurogesX Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
NeurogesX Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
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
84107
Country
United States
Facility Name
NeurogesX Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

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NGX-4010 for the Treatment of Postherpetic Neuralgia

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