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NGX-4010 for Painful HIV-Associated Neuropathy

NCT00321672Phase 3

Key facts

Status: Completed
Start: Jun 2006
Primary completion: Dec 2007
Sponsor: NeurogesX
Modality: Transdermal Patches, Small Molecules

Drugs: capsaicin 8% patch
Conditions: HIV-associated distal sensory polyneuropathy (HIV-DSP)

Overview

Phase 3, randomised, double-blind trial of capsaicin 8% patch in HIV-associated distal sensory polyneuropathy (HIV-DSP) (4 arms), sponsored by NeurogesX. Primary endpoint: Percent Change in the Average Pain for the Past 24 Hours Numeric Pain Rating Scale (NPRS) Score From Baseline at 12 weeks. Started Jun 2006; status: completed.

Design

4 arms

Study design: RandomizedDouble-blind

NGX-4010 60 min
8% capsaicin patch applied for 60 minutes
NGX-4010 30 min
8% capsaicin patch applied for 30 minutes
Control 60 min
0.04% capsaicin patch applied for 60 minutes
Control 30 min
0.04% capsaicin patch applied for 30 minutes

Who it enrols

Patients with documented HIV-1 infection and painful HIV-associated distal symmetric polyneuropathy for at least 2 months, with NPRS scores of 3-9. Excludes patients with uncontrolled diabetes, B12 deficiency, or recent use of neurotoxic antiretrovirals.

Endpoints

Primary

Percent Change in the Average Pain for the Past 24 Hours Numeric Pain Rating Scale (NPRS) Score From Baseline12 weeks

Secondary

Absolute Change in the Mean Average Pain for the Past 24 Hours Numeric Pain Rating Scale (NPRS) Score From Baseline12 weeks
Proportion of Subjects Reaching 30% Decrease in Their Mean Average Pain for the Past 24 Hours Numeric Pain Rating Scale (NPRS) Score From Baseline12 weeks

Results

Not all primary endpoints met

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