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

Information source: NeurogesX
ClinicalTrials.gov processed this data on August 20, 2015
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: Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

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

Page last updated: August 20, 2015

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