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

This study has been terminated.

First Received: August 6, 2004 Last Updated: 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:	Treatment, Open Label, Safety/Efficacy Study
Official Title:	An Open-Label Extension Study of NGX-4010 for the Treatment of Neuropathic Pain

Resource links provided by NLM:

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

Drug Information available for: Capsaicin

U.S. FDA Resources

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

Study ID Numbers:	C114
Study First Received:	August 6, 2004
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00089557 History of Changes
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:

Communicable Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Physiological Effects of Drugs
Pain
Infection
Signs and Symptoms
Neuromuscular Diseases
Sensory System Agents
Therapeutic Uses
Antipruritics
Dermatologic Agents
Retroviridae Infections
Diabetes Complications
Herpes Zoster

RNA Virus Infections
Metabolic Diseases
Neuralgia
Diabetic Neuropathies
Immune System Diseases
Nervous System Diseases
Acquired Immunodeficiency Syndrome
Polyneuropathies
Diabetes Mellitus
Endocrine System Diseases
Capsaicin
Pharmacologic Actions
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on February 08, 2010