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

Pain Clinical Trial

Official title:

A Randomized, Double-Blind, Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068081
• Other study ID #: C110
• Status: Completed
• Phase: Phase 3
• First received: September 5, 2003
• Last updated: March 4, 2008

Study information

• Verified date: September 2007
• Source: NeurogesX
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Zoster
• Nervous System Diseases
• Neuralgia
• Neuralgia, Postherpetic
• Pain
• Peripheral Nervous System Diseases

Intervention

Drug:
• Capsaicin Dermal Patch

Locations

Country	Name	City	State
United States	NeurogesX Investigational Site	Atlanta	Georgia
United States	NeurogesX Investigational Site	Boynton Beach	Florida
United States	NeurogesX Investigational Site	Bradenton	Florida
United States	NeurogesX Investigational Site	Brighton	Massachusetts
United States	NeurogesX Investigational Site	Dallas	Texas
United States	NeurogesX Investigational Site	Duarte	California
United States	NeurogesX Investigational Site	Fort Myers	Florida
United States	NeurogesX Investigational Site	Marietta	Georgia
United States	NeurogesX Investigational Site	Mesa	Arizona
United States	NeurogesX Investigational Site	Naples	Florida
United States	NeurogesX Investigational Site	Peoria	Arizona
United States	NeurogesX Investigational Site	Phoenix	Arizona
United States	NeurogesX Investigational Site	Salt Lake City	Utah
United States	NeurogesX Investigational Site	San Antonio	Texas
United States	NeurogesX Investigational Site	Santa Rosa	California
United States	NeurogesX Investigational Site	St. Louis	Missouri
United States	NeurogesX Investigational Site	St. Louis	Missouri
United States	NeurogesX Investigational Site	Tampa	Florida
United States	NeurogesX Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
NeurogesX

Country where clinical trial is conducted

United States,