NGX-4010 for the Treatment of Postherpetic Neuralgia - Full Text View

Sponsor:	NeurogesX
Information provided by:	NeurogesX
ClinicalTrials.gov Identifier:	NCT00061776

Purpose

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).

Condition	Intervention	Phase
Herpes Zoster Neuralgia Pain Peripheral Nervous System Diseases Shingles	Drug: Capsaicin Dermal Patch	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Postherpetic Neuralgia

Resource links provided by NLM:

MedlinePlus related topics: Neurologic Diseases Peripheral Nerve Disorders Shingles

Drug Information available for: Capsaicin

U.S. FDA Resources

Further study details as provided by NeurogesX:

Estimated Enrollment:

300

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061776

Show 28 Study Locations

Sponsors and Collaborators

NeurogesX

More Information

No publications provided

Study ID Numbers:	C108
Study First Received:	June 3, 2003
Last Updated:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00061776 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NeurogesX:

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

Additional relevant MeSH terms:

Herpes Zoster
Neuralgia, Postherpetic
Neuralgia
Physiological Effects of Drugs
Nervous System Diseases
Pain
Capsaicin
Pharmacologic Actions
Herpesviridae Infections
Virus Diseases

Signs and Symptoms
Neuromuscular Diseases
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Diseases
Antipruritics
Neurologic Manifestations
DNA Virus Infections
Peripheral Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on November 25, 2009