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

This study has been terminated.

First Received on August 6, 2004. Last Updated on June 23, 2005 History of Changes

Sponsor:	NeurogesX
Information provided by:	NeurogesX
ClinicalTrials.gov Identifier:	NCT00089557

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

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus complement factor I deficiency

MedlinePlus related topics: Diabetic Nerve Problems HIV/AIDS Neurologic Diseases Peripheral Nerve Disorders Shingles

Drug Information available for: Capsaicin

U.S. FDA Resources

Further study details as provided by NeurogesX:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

ClinicalTrials.gov 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:

Dermal assessment
Pain assessment
Diary
Analgesics
Capsaicin
Herpes zoster
Neuralgia

Pain
HIV Infections
Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Polyneuropathies
Complementary Therapies

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Diabetes Mellitus
Diabetic Neuropathies
Herpes Zoster
Nervous System Diseases
Neuralgia
Peripheral Nervous System Diseases
Polyneuropathies
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases

Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Diabetes Complications
Herpesviridae Infections
DNA Virus Infections
Pain
Neurologic Manifestations
Signs and Symptoms
Capsaicin
Sensory System Agents

ClinicalTrials.gov processed this record on February 09, 2012