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

January 3, 2008 updated by: NeurogesX

A Randomized, Open-Label Study of the Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • NeurogesX Investigational Site
      • Mobile, Alabama, United States, 36608
        • NeurogesX Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • NeurogesX Investigational Site
    • California
      • Fountain Valley, California, United States, 92708
        • NeurogesX Investigational Site
      • Los Gatos, California, United States, 95032
        • NeurogesX Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80209
        • NeurogesX Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33765
        • NeurogesX Investigational Site
      • New Port Richey, Florida, United States, 34652
        • NeurogesX Investigational Site
      • North Miami, Florida, United States, 33161
        • NeurogesX Investigational Site
      • Plantation, Florida, United States, 33324
        • NeurogesX Investigational Site
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • NeurogesX Investigational Site
    • Massachusetts
      • Wellesley Hills, Massachusetts, United States, 02481-2106
        • NeurogesX Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • NeurogesX Investigational Site
    • New Jersey
      • Greensboro, New Jersey, United States, 27408
        • NeurogesX Investigational Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • NeurogesX Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • NeurogesX Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • NeurogesX Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeurogesX

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 5, 2004

First Submitted That Met QC Criteria

May 6, 2004

First Posted (Estimate)

May 7, 2004

Study Record Updates

Last Update Posted (Estimate)

January 11, 2008

Last Update Submitted That Met QC Criteria

January 3, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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