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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NeurogesX
• Treatments: Capsaicin

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.