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

NeurogesX

Status and phase: Terminated; Phase 2

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

Treatments: Drug: Capsaicin Dermal Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT00089557

C114

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.