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NGX-4010 for the Treatment of Postherpetic Neuralgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00061776
First Posted: June 4, 2003
Last Update Posted: March 6, 2008
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.
Information provided by:
NeurogesX
  Purpose
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 Intervention Phase
Herpes Zoster Neuralgia Pain Peripheral Nervous System Diseases Shingles Drug: Capsaicin Dermal Patch Phase 2 Phase 3

Study Type: Interventional
Study Design: 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 NLM:


Further study details as provided by NeurogesX:

Estimated Enrollment: 300
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00061776


  Show 28 Study Locations
Sponsors and Collaborators
NeurogesX
  More Information

ClinicalTrials.gov Identifier: NCT00061776     History of Changes
Other Study ID Numbers: C108
First Submitted: June 3, 2003
First Posted: June 4, 2003
Last Update Posted: March 6, 2008
Last Verified: March 2008

Keywords provided by NeurogesX:
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

Additional relevant MeSH terms:
Neuralgia
Nervous System Diseases
Herpes Zoster
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Pain
Neurologic Manifestations
Neuromuscular Diseases
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs