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NCT00089557 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00089557
Other study ID # C114
Secondary ID
Status Terminated
Phase Phase 2
First received August 6, 2004
Last updated June 23, 2005

Study information
Verified date September 2004
Source NeurogesX
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Capsaicin Dermal Patch

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
NeurogesX
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