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Clinical Trials/NCT00061776
NCT00061776CompletedPhase 2

A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Postherpetic Neuralgia

NeurogesX29 sites in 1 country300 target enrollmentStarted: June 4, 2003Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
300
Locations
29

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion 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.

Exclusion Criteria

  • Not provided

Investigators

Sponsor
NeurogesX
Sponsor Class
Industry

Study Sites (29)

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