NGX-4010 for the Treatment of Postherpetic Neuralgia - Tabular View

Tracking Information
First Received Date ^ICMJE	June 3, 2003
Last Updated Date	March 4, 2008
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00061776 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	NGX-4010 for the Treatment of Postherpetic Neuralgia
Official Title ^ICMJE	A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
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.
Study Phase	Phase II, Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Dose Comparison, Safety/Efficacy Study
Condition ^ICMJE	Herpes Zoster Neuralgia Pain Peripheral Nervous System Diseases Shingles
Intervention ^ICMJE	Drug: Capsaicin Dermal Patch
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	300
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00061776
Responsible Party
Study ID Numbers ^ICMJE	C108
Study Sponsor ^ICMJE	NeurogesX
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NeurogesX
Verification Date	March 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP