Status:
COMPLETED
Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain
Lead Sponsor:
NeurogesX
Conditions:
Herpes Zoster
Neuralgia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is a randomized, open-label multi-center evaluation of the tolerability of treatment with NGX-4010 in conjunction with pre-patch topical application of one of three 4% lidocaine-based local...
Eligibility Criteria
Inclusion
- Key Eligibility Criteria:
- Must have had for at least 3 months painful diabetic neuropathy, or postherpetic neuralgia, or painful HIV-associated neuropathy, with moderate to severe pain on average.
- Must not have significant pain due to other causes (for example, arthritis).
- Must have intact 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 (12 weeks).
- Must not use topical pain medications on painful areas.
- Must be able to comply with study requirements such as completing daily pain diary and attending study visits and refrain from extensive travel during study participation.
- Must be at least 18 years old, not pregnant, and able to take care of self independently, with only occasional assistance if needed.
- No significant medical problems of the heart, kidneys, liver or lungs, or cancer.
- No history or current problem with substance abuse.
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00082316
Last Update
January 11 2008
Active Locations (17)
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1
NeurogesX Investigational Site
Huntsville, Alabama, United States, 35801
2
NeurogesX Investigational Site
Mobile, Alabama, United States, 36608
3
NeurogesX Investigational Site
Phoenix, Arizona, United States, 85023
4
NeurogesX Investigational Site
Fountain Valley, California, United States, 92708