Clinical trial NCT00068081: Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
Official title: A Randomized, Double-Blind, Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Neuralgia
Pain
Peripheral Nervous System Diseases
Keywords: 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
Lead sponsor: NeurogesX
Sponsor class: INDUSTRY
First posted: 2003-09-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: NeurogesX Investigational Site
state: Arizona
city: Peoria
country: United States
facility: NeurogesX Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: NeurogesX Investigational Site
state: Arizona
city: Duarte
country: United States
facility: NeurogesX Investigational Site
state: California
city: Santa Rosa
country: United States
facility: NeurogesX Investigational Site
state: California
city: Boynton Beach
country: United States
facility: NeurogesX Investigational Site
state: Florida
city: Bradenton
country: United States
facility: NeurogesX Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: NeurogesX Investigational Site
state: Florida
city: Naples
country: United States
facility: NeurogesX Investigational Site
state: Florida
city: Tampa
country: United States
facility: NeurogesX Investigational Site
state: Florida
city: Atlanta
country: United States
facility: NeurogesX Investigational Site
state: Georgia
city: Marietta
country: United States
facility: NeurogesX Investigational Site
state: Georgia
city: Brighton
country: United States
facility: NeurogesX Investigational Site
state: Massachusetts
city: St. Louis
country: United States
facility: NeurogesX Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: NeurogesX Investigational Site
state: Missouri
city: Winston-Salem
country: United States
facility: NeurogesX Investigational Site
state: North Carolina
city: Dallas
country: United States
facility: NeurogesX Investigational Site
state: Texas
city: San Antonio
country: United States
facility: NeurogesX Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: NeurogesX Investigational Site
state: Utah
Study officials:
References:
citation: Webster LR, Tark M, Rauck R, Tobias JK, Vanhove GF. Effect of duration of postherpetic neuralgia on efficacy analyses in a multicenter, randomized, controlled study of NGX-4010, an 8% capsaicin patch evaluated for the treatment of postherpetic neuralgia. BMC Neurol. 2010 Oct 11;10:92. doi: 10.1186/1471-2377-10-92.