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

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Capsaicin Dermal Patch

About this trial

This is an interventional treatment trial for Herpes Zoster focused on measuring Dermal assessment, Pain assessment, Diary, Analgesics, Capsaicin, Herpes zoster, Neuralgia, Pain, HIV Infections, Peripheral Nervous System Diseases, Diabetic Neuropathies, Diabetes Mellitus, Polyneuropathies, Complementary Therapies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00089557

First Posted

August 6, 2004

Last Updated

June 23, 2005

Sponsor

NeurogesX

1. Study Identification

Unique Protocol Identification Number

NCT00089557

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2004

Overall Recruitment Status

Terminated

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

NeurogesX

4. Oversight

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Capsaicin Dermal Patch

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Herpes Zoster, Neuralgia, Pain

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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