Completed

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

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What is being tested

Capsaicin Dermal Patch

Drug
Who is being recruted

Herpes Zoster
+5

+ Neuralgia
+ Pain
Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional

See protocol details

Summary

Principal SponsorNeurogesX
Last updated: January 11, 2008
Sourced from a government-validated database.Claim as a partner

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).

Official TitleA Randomized, Open-Label Study of the Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain 
Principal SponsorNeurogesX
Last updated: January 11, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Herpes Zoster
Neuralgia
Pain
HIV Infections
Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Polyneuropathies
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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 17 locations
Suspended
NeurogesX Investigational SiteHuntsville, United StatesSee the location
Suspended
NeurogesX Investigational SiteMobile, United States
Suspended
NeurogesX Investigational SitePhoenix, United States
Suspended
NeurogesX Investigational SiteFountain Valley, United States
Completed17 Study Centers