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

Tracking Information
First Submitted Date ICMJE	May 5, 2004
First Posted Date ICMJE	May 7, 2004
Last Update Posted Date	January 11, 2008
Study 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: None (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
Original Enrollment ICMJE	Not Provided
Study 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, Older Adult)
Accepts Healthy Volunteers	No
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