An Open-Label Extension Study of NGX-4010 for the Treatment of Neuropathic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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

Detailed Description

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Conditions

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Herpes Zoster Neuralgia Pain HIV Infections Peripheral Nervous System Diseases Diabetic Neuropathies Diabetes Mellitus Polyneuropathies

Keywords

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Dermal assessment Pain assessment Diary Analgesics Capsaicin Herpes zoster Neuralgia Pain HIV Infections Peripheral Nervous System Diseases Diabetic Neuropathies Diabetes Mellitus Polyneuropathies Complementary Therapies

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Capsaicin Dermal Patch

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Other Identifiers

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C114

Identifier Type: -

Identifier Source: org_study_id