Occipital Neuralgia |
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Clinical Trial: An Open-Label Extension Study of NGX-4010 for the Treatment of Neuropathic Pain
This study has been terminated.
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Purpose
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
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Herpes Zoster Neuralgia Pain HIV Infections Peripheral Nervous System Diseases Diabetic Neuropathies Diabetes Mellitus Polyneuropathies | Drug: Capsaicin Dermal Patch | Phase II |
MedlinePlus related topics: AIDS; Diabetes; Diabetic Nerve Problems; Pain; Peripheral Nerve Disorders; Shingles
Study Type: Interventional
Study Design: Treatment, Open Label, Safety/Efficacy Study
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: 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.
More Information
Record last reviewed: September 2004
Last Updated: October 13, 2004
Record first received: August 6, 2004
ClinicalTrials.gov Identifier: NCT00089557
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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