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


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Occipital Neuralgia


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

This study has been terminated.

Sponsored by: NeurogesX
Information provided by: NeurogesX

Purpose

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

Condition Treatment or Intervention Phase
Herpes Zoster
Neuralgia
Pain
HIV Infections
Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Polyneuropathies
 Drug: Capsaicin Dermal Patch
Phase II

MedlinePlus related topics:  AIDS;   Diabetes;   Diabetic Nerve Problems;   Pain;   Peripheral Nerve Disorders;   Shingles

Study Type: Interventional
Study Design: Treatment, Open Label, Safety/Efficacy Study

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

More Information

Study ID Numbers:  C114
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  August 6, 2004
ClinicalTrials.gov Identifier:  NCT00089557
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 6, 2008



Page Updated: September 6, 2005
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