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

This study has been terminated.
Information provided by:
NeurogesX Identifier:
First received: August 6, 2004
Last updated: June 23, 2005
Last verified: September 2004
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 Intervention Phase
Herpes Zoster
HIV Infections
Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Drug: Capsaicin Dermal Patch
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Masking: 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 NLM:

Further study details as provided by NeurogesX:


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information Identifier: NCT00089557     History of Changes
Other Study ID Numbers: C114 
Study First Received: August 6, 2004
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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:
Diabetic Neuropathies
HIV Infections
Diabetes Mellitus
Herpes Zoster
Nervous System Diseases
Peripheral Nervous System Diseases
DNA Virus Infections
Diabetes Complications
Endocrine System Diseases
Glucose Metabolism Disorders
Herpesviridae Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Metabolic Diseases
Neurologic Manifestations
Neuromuscular Diseases
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Signs and Symptoms
Virus Diseases
Dermatologic Agents
Peripheral Nervous System Agents processed this record on May 22, 2016