An Open-Label Extension Study of NGX-4010 for the Treatment of Neuropathic Pain
Information source: NeurogesX
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Zoster; Neuralgia; Pain; HIV Infections; Peripheral Nervous System Diseases; Diabetic Neuropathies; Diabetes Mellitus; Polyneuropathies
Intervention: Capsaicin Dermal Patch (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: NeurogesX
Summary
This study is an open-label, multicenter, extension study for subjects who completed
NeurogesX Study C111 and received treatment with NGX-4010 (Capsaicin Patch) within 12 weeks
(up to +7days) before entry into Study C114
Clinical Details
Official title: An Open-Label Extension Study of NGX-4010 for the Treatment of Neuropathic Pain
Study design: Treatment, Open Label, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Key Eligibility Criteria:
- Must have completed NeurogesX Study C111 and received treatment with NGX-4010
(Capsaicin Patch) within 12 weeks (up to +7 days) before entry into Study C114.
- Demonstrated adherence to protocol requirements during Study C111, and willing and
able to comply with protocol requirements for the duration of the study
participation.
- Must not have had any serious adverse experience since enrollment in Study C111,
whether or not considered to be study drug-related.
- 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 (36 weeks).
- Must not use topical pain medications on painful areas.
- Must be at least 18 years old, not pregnant, and able to take care of self
independently, with only occasional assistance if needed.
- No history or current problem with substance abuse.
Locations and Contacts
Additional Information
Last updated: June 23, 2005
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