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

Information source: NeurogesX
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Zoster; Neuralgia; Pain; Peripheral Nervous System Diseases

Intervention: Capsaicin Dermal Patch (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: NeurogesX

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.

Clinical Details

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

NeurogesX Investigational Site, Mesa, Arizona 85210, United States

NeurogesX Investigational Site, Peoria, Arizona 85381, United States

NeurogesX Investigational Site, Phoenix, Arizona 85032, United States

NeurogesX Investigational Site, Duarte, California 91010, United States

NeurogesX Investigational Site, Santa Rosa, California 95403, United States

NeurogesX Investigational Site, Boynton Beach, Florida 33437, United States

NeurogesX Investigational Site, Bradenton, Florida 34205, United States

NeurogesX Investigational Site, Fort Myers, Florida 33907, United States

NeurogesX Investigational Site, Naples, Florida 34102, United States

NeurogesX Investigational Site, Tampa, Florida 33614, United States

NeurogesX Investigational Site, Atlanta, Georgia 30328, United States

NeurogesX Investigational Site, Marietta, Georgia 30060, United States

NeurogesX Investigational Site, Brighton, Massachusetts 02135, United States

NeurogesX Investigational Site, St. Louis, Missouri 63141, United States

NeurogesX Investigational Site, St. Louis, Missouri 63108, United States

NeurogesX Investigational Site, Winston-Salem, North Carolina 27103, United States

NeurogesX Investigational Site, Dallas, Texas 75235, United States

NeurogesX Investigational Site, San Antonio, Texas 78229, United States

NeurogesX Investigational Site, Salt Lake City, Utah 84107, United States

Additional Information


Last updated: March 4, 2008

Page last updated: August 20, 2015

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