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

This study has been completed.
Sponsor:
Information provided by:
NeurogesX
ClinicalTrials.gov Identifier:
NCT00068081
First received: September 5, 2003
Last updated: March 4, 2008
Last verified: September 2007
  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 3

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

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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

Locations
United States, Arizona
NeurogesX Investigational Site
Mesa, Arizona, United States, 85210
NeurogesX Investigational Site
Peoria, Arizona, United States, 85381
NeurogesX Investigational Site
Phoenix, Arizona, United States, 85032
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
Boynton Beach, Florida, United States, 33437
NeurogesX Investigational Site
Bradenton, Florida, United States, 34205
NeurogesX Investigational Site
Fort Myers, Florida, United States, 33907
NeurogesX Investigational Site
Naples, Florida, United States, 34102
NeurogesX Investigational Site
Tampa, Florida, United States, 33614
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
Dallas, Texas, United States, 75235
NeurogesX Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
NeurogesX Investigational Site
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
NeurogesX
  More Information

No publications provided by NeurogesX

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00068081     History of Changes
Other Study ID Numbers: C110
Study First Received: September 5, 2003
Last Updated: March 4, 2008
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

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

ClinicalTrials.gov processed this record on September 16, 2014