An Open-Label Extension Study of NGX-4010 for the Treatme... | NCT00089557

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

NCT00089557

Sponsor

NeurogesX

Status

Terminated

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

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

Interventions

Capsaicin Dermal Patch

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2004

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 6, 2004

First Submission Date that Met QC Criteria

Aug 6, 2004

First Posted Date

Aug 9, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Description Module

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

Detailed Description

Not provided

Conditions Module

Conditions

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Capsaicin Dermal Patch	Drug

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006562	Herpes Zoster
D009437	Neuralgia
D010146	Pain
D015658	HIV Infections
D010523	Peripheral Nervous System Diseases
D003929	Diabetic Neuropathies
D003920	Diabetes Mellitus
D011115	Polyneuropathies

Ancestor Terms

ID	Term
D000073618	Varicella Zoster Virus Infection
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided