Clinical trial NCT00061776: NGX-4010 for the Treatment of Postherpetic Neuralgia
Official title: A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Herpes Zoster
Neuralgia
Pain
Peripheral Nervous System Diseases
Shingles
Keywords: Dermal assessment
Pain measurement
Diary
Shingles
Neuropathy
Analgesics/*therapeutic use
Capsaicin/*administration & dosage/adverse effects
Herpes Zoster/*complications/drug therapy
Neuralgia/*drug therapy/etiology
Pain
Peripheral Nervous System Diseases/*complications
Lead sponsor: NeurogesX
Sponsor class: INDUSTRY
First posted: 2003-06-04
Enrollment: 300
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 determine if an investigational drug, NGX-4010 (high-concentration capsaicin dermal patches) is effective in treating pain associated with post-herpetic neuralgia (PHN).

Detailed description: Participants will be randomly assigned to receive initial treatment according to one of three doses (application durations), and will receive either NGX-4010 patch (high-concentration capsaicin) or matching control (low-concentration capsaicin).

Participants who complete the study evaluations for 12 weeks will have the option of receiving up to 3 additional open-label re-treatments over 1 year.

Eligibility criteria: Key Eligibility Criteria:

* Must be diagnosed with PHN and be at least 6 months after crusting of the skin vesicles, with moderate to severe pain.
* Must not have significant pain due to causes other than PHN (for example, arthritis).
* Painful areas should not be located on the face, above the hairline of the scalp, and/or in proximity to mucous membranes.
* Must have intact and unbroken skin at the treatment area.
* Must be prepared to remain on the same pain medications at the same doses as before the study for the entire duration of the study (1-year).
* Must not have any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of pain.
* Must not use topical pain medications for PHN.
* Must be able to comply with study requirements such as completing a daily pain diary, attending study visits and refraining from extensive travel during study participation.
* No significant medical problems of the heart, kidneys, liver or lungs, or cancer.
* No history or current problem with substance abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: NeurogesX Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: NeurogesX Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: NeurogesX Investigational Site
state: Arizona
city: Tucson
country: United States
facility: NeurogesX Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: NeurogesX Investigational Site
state: Arkansas
city: La Jolla
country: United States
facility: NeurogesX Investigational Site
state: California
city: San Francisco
country: United States
facility: NeurogesX Investigational Site
state: California
city: Denver
country: United States
facility: NeurogesX Investigational Site
state: Colorado
city: Melbourne
country: United States
facility: NeurogesX Investigational Site
state: Florida
city: Naples
country: United States
facility: NeurogesX Investigational Site
state: Florida
city: Ocala
country: United States
facility: NeurogesX Investigational Site
state: Florida
city: Palm Beach Garden
country: United States
facility: NeurogesX Investigational Site
state: Florida
city: Plantation
country: United States
facility: NeurogesX Investigational Site
state: Florida
city: Sarasota
country: United States
facility: NeurogesX Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: NeurogesX Investigational Site
state: Florida
city: Boston
country: United States
facility: NeurogesX Investigational Site
state: Massachusetts
city: Kansas City
country: United States
facility: NeurogesX Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: NeurogesX Investigational Site
state: Nevada
city: Morristown
country: United States
facility: NeurogesX Investigational Site
state: New Jersey
city: Albany
country: United States
facility: NeurogesX Investigational Site
state: New York
city: Rochester
country: United States
facility: NeurogesX Investigational Site
state: New York
city: Eugene
country: United States
facility: NeurogesX Investigational Site
state: Oregon
city: Memphis
country: United States
facility: NeurogesX Investigational Site
state: Tennessee
city: Austin
country: United States
facility: NeurogesX Investigational Site
state: Texas
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
city: Tacoma
country: United States
facility: NeurogesX Investigational Site
state: Washington
Study officials:
References: