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Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia

This study has been completed.

Sponsored by: NeurogesX
Information provided by: NeurogesX
ClinicalTrials.gov Identifier: NCT00068081
  Purpose

The purpose of the study is to assess the efficacy, safety and tolerability of NGX 4010 applied for 60 minutes for the treatment of PHN.


Condition Intervention Phase
Herpes Zoster
Neuralgia
Pain
Peripheral Nervous System Diseases
Drug: Capsaicin Dermal Patch
Phase III

MedlinePlus related topics:   Neurologic Diseases    Peripheral Nerve Disorders    Shingles   

Drug Information available for:   Capsaicin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Safety/Efficacy Study
Official Title:   A Randomized, Double-Blind, Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia

Further study details as provided by NeurogesX:

Estimated Enrollment:   150

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • At least 18 years of age.
  • Be in good health.
  • Diagnosis of postherpetic neuralgia (PHN) made by the primary treating physician or Investigator, and at least 3 months post-vesicle crusting.
  • Screening Pain Sum Score of 12 to 36.
  • Intact, unbroken skin over the painful area(s) to be treated.
  • If taking chronic pain medications, be on a stable (not PRN) regimen for at least 21 days prior to Treatment Visit (Day 0) and willing to maintain medications at same stable dose(s) and schedule throughout the study.
  • Female subjects with child-bearing potential must have a negative serum beta hCG pregnancy test, to be performed at the Screening Visit.
  • All subjects must be willing to use effective methods of birth control and/or refrain from participating in a conception process during the study and for 30 days following experimental drug exposure.
  • Be willing and able to comply with protocol requirements for the duration of study participation. (Such requirements include, but are not limited to: completing a daily pain diary, attending all study visits, and refraining from elective surgery and extensive travel during study participation.)

Exclusion Criteria:

  • Concomitant opioid medication, unless orally or transdermally administered and not exceeding a total daily dose of morphine 60 mg/day, or equivalent. Parenteral opioid use is excluded, regardless of dose.
  • Unavailability of an effective rescue medication strategy for the subject, such as unwillingness to use opioid analgesics during treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with Roxicodone®, as judged by the Investigator.
  • Active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse judged likely to recur during the study period by the investigator.
  • Recent use (within 21 days preceding the Treatment Visit [Day 0]) of any topically applied pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including Lidoderm®), steroids or capsaicin products on the painful areas.
  • Current use of any investigational agent, or Class 1 anti-arrhythmic drugs (such as tocainide and mexiletine).
  • Significant pain of an etiology other than PHN, for example, compression-related neuropathies (e.g., spinal stenosis) or fibromyalgia or arthritis. Subjects must not have significant ongoing pain from other cause(s) that may interfere with judging PHN-related pain.
  • Painful PHN areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes. (Investigational treatment with NGX-4010 is not allowed in these areas.)
  • Any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
  • Hypersensitivity to capsaicin (i.e., chili peppers or Over-the-Counter (OTC) capsaicin products), local anesthetics, Roxicodone® or adhesives.
  • Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may interfere either with the ability to complete the study or the evaluation of adverse events.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068081

Locations
United States, Arizona
NeurogesX Investigational Site    
      Peoria, Arizona, United States, 85381
NeurogesX Investigational Site    
      Phoenix, Arizona, United States, 85032
NeurogesX Investigational Site    
      Mesa, Arizona, United States, 85210
United States, California
NeurogesX Investigational Site    
      Duarte, California, United States, 91010
NeurogesX Investigational Site    
      Santa Rosa, California, United States, 95403
United States, Florida
NeurogesX Investigational Site    
      Naples, Florida, United States, 34102
NeurogesX Investigational Site    
      Boynton Beach, Florida, United States, 33437
NeurogesX Investigational Site    
      Fort Myers, Florida, United States, 33907
NeurogesX Investigational Site    
      Tampa, Florida, United States, 33614
NeurogesX Investigational Site    
      Bradenton, Florida, United States, 34205
United States, Georgia
NeurogesX Investigational Site    
      Atlanta, Georgia, United States, 30328
NeurogesX Investigational Site    
      Marietta, Georgia, United States, 30060
United States, Massachusetts
NeurogesX Investigational Site    
      Brighton, Massachusetts, United States, 02135
United States, Missouri
NeurogesX Investigational Site    
      St. Louis, Missouri, United States, 63141
NeurogesX Investigational Site    
      St. Louis, Missouri, United States, 63108
United States, North Carolina
NeurogesX Investigational Site    
      Winston-Salem, North Carolina, United States, 27103
United States, Texas
NeurogesX Investigational Site    
      San Antonio, Texas, United States, 78229
NeurogesX Investigational Site    
      Dallas, Texas, United States, 75235
United States, Utah
NeurogesX Investigational Site    
      Salt Lake City, Utah, United States, 84107

Sponsors and Collaborators
NeurogesX
  More Information


Study ID Numbers:   C110
First Received:   September 5, 2003
Last Updated:   March 4, 2008
ClinicalTrials.gov Identifier:   NCT00068081
Health Authority:   United States: Food and Drug Administration

Keywords provided by NeurogesX:
Dermal assessment  
Pain measurement  
Diary  
Analgesics/*therapeutic use  
Capsaicin/*administration & dosage/adverse effects  
Herpes zoster/*complication/drug therapy
Neuralgia/*drug therapy/etiology
Pain
Peripheral nervous system diseases/*complications

Study placed in the following topic categories:
Virus Diseases
Neuralgia, Postherpetic
Herpes Zoster
Signs and Symptoms
Neuromuscular Diseases
Neuralgia
Peripheral Nervous System Diseases
Neurologic Manifestations
DNA Virus Infections
Pain
Capsaicin
Herpesviridae Infections

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Antipruritics
Peripheral Nervous System Agents
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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