Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain

This study has been completed.

Sponsor:

Information provided by:

NeurogesX

ClinicalTrials.gov Identifier:

NCT00082316

First received: May 5, 2004

Last updated: January 3, 2008

Last verified: January 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

May 5, 2004

Last Updated Date

January 3, 2008

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00082316 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain

Official Title ^ICMJE

A Randomized, Open-Label Study of the Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain

Brief Summary

This study is a randomized, open-label multi-center evaluation of the tolerability of treatment with NGX-4010 in conjunction with pre-patch topical application of one of three 4% lidocaine-based local anesthetic products. Eligible subjects will have moderate to severe neuropathic pain secondary to painful diabetic neuropathy (PDN), postherpetic neuralgia (PHN) or HIV-associated neuropathy (HIV-AN), with average numeric pain rating scale (NPRS) scores during screening of 3 to 8 (inclusive).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: Capsaicin Dermal Patch

Study Arms

Not Provided

Publications *

Webster LR, Peppin JF, Murphy FT, Lu B, Tobias JK, Vanhove GF. Efficacy, safety, and tolerability of NGX-4010, capsaicin 8% patch, in an open-label study of patients with peripheral neuropathic pain. Diabetes Res Clin Pract. 2011 Aug;93(2):187-97. doi: 10.1016/j.diabres.2011.04.010. Epub 2011 May 25.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Key Eligibility Criteria:

Must have had for at least 3 months painful diabetic neuropathy, or postherpetic neuralgia, or painful HIV-associated neuropathy, with moderate to severe pain on average.
Must not have significant pain due to other causes (for example, arthritis).
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 (12 weeks).
Must not use topical pain medications on painful areas.
Must be able to comply with study requirements such as completing daily pain diary and attending study visits and refrain from extensive travel during study participation.
Must be at least 18 years old, not pregnant, and able to take care of self independently, with only occasional assistance if needed.
No significant medical problems of the heart, kidneys, liver or lungs, or cancer.
No history or current problem with substance abuse.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00082316

Other Study ID Numbers ^ICMJE

C111

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

NeurogesX

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

NeurogesX

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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