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

This study has been terminated.
Sponsor:
Information provided by:
NeurogesX
ClinicalTrials.gov Identifier:
NCT00089557
First received: August 6, 2004
Last updated: June 23, 2005
Last verified: September 2004

August 6, 2004
June 23, 2005
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Complete list of historical versions of study NCT00089557 on ClinicalTrials.gov Archive Site
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An Open-Label Extension Study of NGX-4010 for the Treatment of Neuropathic Pain
An Open-Label Extension Study of NGX-4010 for the Treatment of Neuropathic Pain

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

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Interventional
Phase 2
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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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00089557
C114
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NeurogesX
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NeurogesX
September 2004

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