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

May 5, 2004
January 3, 2008
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Complete list of historical versions of study NCT00082316 on ClinicalTrials.gov Archive Site
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Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain
A Randomized, Open-Label Study of the Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain

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).

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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
  • Herpes Zoster
  • Neuralgia
  • Pain
  • HIV Infections
  • Peripheral Nervous System Diseases
  • Diabetic Neuropathies
  • Diabetes Mellitus
  • Polyneuropathies
Drug: Capsaicin Dermal Patch
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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.
 
Completed
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00082316
C111
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NeurogesX
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NeurogesX
January 2008

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