Working... Menu

NGX-4010 for the Treatment of Postherpetic Neuralgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00061776
Recruitment Status : Completed
First Posted : June 4, 2003
Last Update Posted : March 6, 2008
Information provided by:

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).

Condition or disease Intervention/treatment Phase
Herpes Zoster Neuralgia Pain Peripheral Nervous System Diseases Shingles Drug: Capsaicin Dermal Patch Phase 2 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Postherpetic Neuralgia

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
Drug Information available for: Capsaicin

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00061776

  Show 28 Study Locations
Sponsors and Collaborators

Layout table for additonal information Identifier: NCT00061776     History of Changes
Other Study ID Numbers: C108
First Posted: June 4, 2003    Key Record Dates
Last Update Posted: March 6, 2008
Last Verified: March 2008

Keywords provided by NeurogesX:
Dermal assessment
Pain measurement
Analgesics/*therapeutic use
Capsaicin/*administration & dosage/adverse effects
Herpes Zoster/*complications/drug therapy
Neuralgia/*drug therapy/etiology
Peripheral Nervous System Diseases/*complications

Additional relevant MeSH terms:
Layout table for MeSH terms
Herpes Zoster
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Neurologic Manifestations
Signs and Symptoms
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs