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Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain

Information source: NeurogesX
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Zoster; Neuralgia; Pain; HIV Infections; Peripheral Nervous System Diseases; Diabetic Neuropathies; Diabetes Mellitus; Polyneuropathies

Intervention: Capsaicin Dermal Patch (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: NeurogesX

Summary

This study is a randomized, open-label multi-center evaluation of the tolerability of treatment with NGX-4010 in conjunction with pre-patch topical application of one of three 4% lidocaine-based local anesthetic products. Eligible subjects will have moderate to severe neuropathic pain secondary to painful diabetic neuropathy (PDN), postherpetic neuralgia (PHN) or HIV-associated neuropathy (HIV-AN), with average numeric pain rating scale (NPRS) scores during screening of 3 to 8 (inclusive).

Clinical Details

Official title: A Randomized, Open-Label Study of the Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Key Eligibility Criteria:

- Must have had for at least 3 months painful diabetic neuropathy, or postherpetic

neuralgia, or painful HIV-associated neuropathy, with moderate to severe pain on average.

- Must not have significant pain due to other causes (for example, arthritis).

- 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 (12 weeks).

- Must not use topical pain medications on painful areas.

- Must be able to comply with study requirements such as completing daily pain diary

and attending study visits and refrain from extensive travel during study participation.

- Must be at least 18 years old, not pregnant, and able to take care of self

independently, with only occasional assistance if needed.

- No significant medical problems of the heart, kidneys, liver or lungs, or cancer.

- No history or current problem with substance abuse.

Locations and Contacts

NeurogesX Investigational Site, Huntsville, Alabama 35801, United States

NeurogesX Investigational Site, Mobile, Alabama 36608, United States

NeurogesX Investigational Site, Phoenix, Arizona 85023, United States

NeurogesX Investigational Site, Fountain Valley, California 92708, United States

NeurogesX Investigational Site, Los Gatos, California 95032, United States

NeurogesX Investigational Site, Denver, Colorado 80209, United States

NeurogesX Investigational Site, Clearwater, Florida 33765, United States

NeurogesX Investigational Site, New Port Richey, Florida 34652, United States

NeurogesX Investigational Site, North Miami, Florida 33161, United States

NeurogesX Investigational Site, Plantation, Florida 33324, United States

NeurogesX Investigational Site, West Des Moines, Iowa 50265, United States

NeurogesX Investigational Site, Wellesley Hills, Massachusetts 02481-2106, United States

NeurogesX Investigational Site, Saint Louis, Missouri 63108, United States

NeurogesX Investigational Site, Greensboro, New Jersey 27408, United States

NeurogesX Investigational Site, Duncansville, Pennsylvania 16635, United States

NeurogesX Investigational Site, San Antonio, Texas 78229, United States

NeurogesX Investigational Site, Salt Lake City, Utah 84106, United States

Additional Information


Last updated: January 3, 2008

Page last updated: August 20, 2015

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