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	Treatment or Intervention	Phase
Herpes Zoster Neuralgia Pain Peripheral Nervous System Diseases Shingles	Drug: Capsaicin Dermal Patch	Phase II Phase III

Further Study Details: 

Expected Total Enrollment:  300

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Alabama
      Center for Pain Management and Rehabilitation, Huntsville,  Alabama,  35801,  United States
Arizona
      Arizona Research Center, Phoenix,  Arizona,  85023,  United States
      University of Arizona, Tucson,  Arizona,  85724,  United States
      Radiant Research, Scottsdale,  Arizona,  United States
Arkansas
      Clinical Study Center, Little Rock,  Arkansas,  72205,  United States
California
      First Clinical Research, San Francisco,  California,  94117,  United States
      UCSD Pain Management Group, La Jolla,  California,  92037,  United States
Colorado
      Colorado Neurology & Headache Center, Denver,  Colorado,  80218,  United States
Florida
      Palm Beach Neurological Center, Palm Beach Garden,  Florida,  33410,  United States
      Neurology Clinical Research, Inc., Plantation,  Florida,  33324,  United States
      Anchor Research Center, Naples,  Florida,  34102,  United States
      Renstar Medical Research, Ocala,  Florida,  34471,  United States
      Comprehensive Neuroscience, Inc., Sarasota,  Florida,  34232,  United States
      Comprehensive Neuroscience, Inc., St. Petersburg,  Florida,  33702,  United States
      Comprehensive Neuroscience, Inc., Melbourne,  Florida,  32935,  United States
Massachusetts
      Brigham and Women's Hospital, Boston,  Massachusetts,  02115,  United States
Missouri
      The Pain Institute, Research Medical Center, Kansas City,  Missouri,  64132,  United States
Nevada
      University of Nevada, Las Vegas,  Nevada,  89102,  United States
New Jersey
      Neuroscience Center of Northern New Jersey, Morristown,  New Jersey,  07960,  United States
New York
      Upstate Clinical Research, Albany,  New York,  12205,  United States
      University of Rochester, Rochester,  New York,  14642,  United States
Oregon
      Pain Consultants of Oregon, Eugene,  Oregon,  97401,  United States
Tennessee
      Methodist Comprehensive Pain Inst., Memphis,  Tennessee,  93104,  United States
Texas
      Radiant Research, Austin,  Texas,  78758,  United States
      Neurology Clinic of San Antonio, San Antonio,  Texas,  78229,  United States
      Research Across America, Dallas,  Texas,  75234,  United States
Utah
      Lifetree Clinical Research, Salt Lake City,  Utah,  84107,  United States
Washington
      Internal Medicine Northwest, Tacoma,  Washington,  98405,  United States

Study ID Numbers:  C108
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  June 3, 2003
ClinicalTrials.gov Identifier:  NCT00061776
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08