NCT00061776CompletedPhase 2
A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
NeurogesX29 sites in 1 country300 target enrollmentStarted: June 4, 2003Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 300
- Locations
- 29
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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.
Exclusion Criteria
- Not provided
Investigators
Study Sites (29)
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