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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00089557
Recruitment Status : Terminated
First Posted : August 9, 2004
Last Update Posted : June 24, 2005
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Herpes Zoster Neuralgia Pain HIV Infections Peripheral Nervous System Diseases Diabetic Neuropathies Diabetes Mellitus Polyneuropathies Drug: Capsaicin Dermal Patch Phase 2

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study of NGX-4010 for the Treatment of Neuropathic Pain

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. Identifier: NCT00089557     History of Changes
Other Study ID Numbers: C114
First Posted: August 9, 2004    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: September 2004

Keywords provided by NeurogesX:
HIV Infections
Diabetic Neuropathies
Dermal assessment
Pain assessment
Herpes zoster
Peripheral Nervous System Diseases
Diabetes Mellitus
Complementary Therapies

Additional relevant MeSH terms:
HIV Infections
Diabetic Neuropathies
Diabetes Mellitus
Nervous System Diseases
Herpes Zoster
Peripheral Nervous System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Herpesviridae Infections
DNA Virus Infections
Dermatologic Agents
Sensory System Agents