Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain

February 6, 2006 updated by: NeurogesX

A Double-Blind Controlled Pilot Study of High-Dose Capsaicin Patches in the Treatment of Pain Associated With Postherpetic Neuralgia

The purpose of this study is to gain initial information on the tolerability of high-dose capsaicin patches in patients with Painful Postherpetic Neuralgia. The study will also collect preliminary information on safety and efficacy.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment

42

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

    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
      • Tucson, Arizona, United States, 85724
        • University of Arizona Health Sciences Center
    • Florida
      • Naples, Florida, United States, 34102
        • Anchor Research Center
      • Palm Beach Gardens, Florida, United States, 33410
        • Palm Beach Neurological Center
      • St. Petersburg, Florida, United States, 33701
        • Suncoast Neuroscience Associates, Inc.
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital, Pain Trials Center
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Pain Management Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital, Neurology Department

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

Eligibility Criteria

Inclusion Criteria:

Patients may be eligible for this study if they:

  • Have a diagnosis of Painful Postherpetic Neuralgia and are at least 6 months post vesicle crusting.
  • Are in good health.
  • Have an adequate pain score during the screening period.
  • Have painful areas (maximum of two sites) below the neck.
  • If female, are of non-childbearing ability as defined by absence of menses for a minimum of 3 months or surgically sterile.
  • If male, are willing to agree to take adequate birth control precautions with their partner for 60 days following experimental drug exposure.
  • Have unbroken skin with good perfusion over the painful area(s).
  • Have the ability to feel capsaicin-mediated sensations, as evidenced by ability to feel topically applied OTC capsaicin cream.
  • Are on a stable and continuous medication regimen, with no change in dosage for 21 days prior to study start, and are willing to maintain concomitant medications at current doses throughout the study.
  • Are willing and able to use oral opioid-based analgesic agents for relief, in case this is needed to relieve acute pain associated with the application of capsaicin patches.
  • Are 18 years of age or older.
  • Are willing and able to comply with the protocol

Exclusion Criteria:

Patients will not be eligible for this study if they:

  • Have diffusely distributed neuropathic pain (i.e., pain that is evident in more than 2 different sites). Subjects must not have significant pain outside the areas to be treated.
  • Have any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
  • Currently (within the past 21 days) use topically applied non-steroidal anti-inflammatory drugs, local anesthetics, steroids or capsaicin products on the painful areas.
  • Currently (within the past 21 days) use topical agents such as lidoderm patch 5%, topical steroids or aspirin.
  • Have a history or current problem with prescription drug or illicit substance abuse (from self report or as judged by investigator).
  • Currently have an abuse problem with alcohol (from self-report or as judged by investigator).
  • Are suspected of psychosocial gain/benefit of continued pain as judged by the investigator or primary treating physician.
  • Plan to travel more than 100 miles from home during the study or engage in unusual activities that might exacerbate pain.
  • Have poor cardiac, renal, hepatic, or pulmonary function judged by the investigator or primary treating physician.
  • Have a laboratory value at screening outside the normal range, unless it is judged by the investigator as not clinically significant after appropriate evaluation.
  • Have hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin products), local anesthetics, oral opioid-based analgesic agents, or adhesives.
  • Have a high tolerance to opioids.
  • Currently using Class 1 anti-arrhythmic drugs (such as tocainide and mexiletine).

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: DOUBLE

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Director: John A Jermano, NeurogesX

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 Major Dates

Study Start

March 1, 2002

Study Completion

October 1, 2002

Study Registration Dates

First Submitted

May 1, 2002

First Submitted That Met QC Criteria

May 1, 2002

First Posted (ESTIMATE)

May 2, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

February 7, 2006

Last Update Submitted That Met QC Criteria

February 6, 2006

Last Verified

February 1, 2006

More Information

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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