CTN 221: NGX-4010 for the treatment of painful HIV-associated neuropathy
A multicenter randomized, double-blind, controlled study of NGX-4010 for the treatment of painful HIV-associated neuropathy: Trial results
About The Study
The purpose of this study was to test the safety and efficacy of treating HIV-associated neuropathy (HIV-AN) with NGX-4010 or capsaicin dermal patch. Participants must have painful HIV-associated neuropathy in both feet. Treatment of painful areas of up to 1000 square centimeters consisted of a single application of dermal patches for a duration of either 30 or 60 minutes. Pain was measured according to the numeric pain rating scale (NPRS) and was recorded daily in the evening in a diary.
Study Approach
This was a randomized, double-blind, controlled study. The study was seeking participants with an average pain score between three and nine on the NPRS. Participants were randomly assigned to one of three groups: group one was treated with active NGX-4010 patches for 30 minutes, group two was treated with low concentration control patches for 30 minutes, group three was treated with active NGX-4010 patches for 60 minutes and group four was treated with low concentration control patches for 60 minutes.
Study Population
A total of 11 participants were recruited from five sites in Alberta, British Columbia, Manitoba, Ontario and Nova Scotia. There were no women enrolled for this trial.
Results
Although the results were not statistically significant, the study found that 29.5 per cent of those in the treatment groups experienced pain relief compared to 24.6 per cent of those in the placebo group. When looking at the individual treatment arms, the 30-minute group treated with NGX-4010 achieved a 26.1 per cent reduction in pain from baseline compared to 19.1 per cent for the control group. The 60-minute group treated with NGX-4010 achieved a 32.8 per cent reduction in pain from baseline compared to 30.1 per cent for the control group.
Conclusions
This study showed that although more people in the treatment groups experienced pain relief compared to placebo, the difference was not statistically significant.
Note: These results were provided by NeurogesX and AIDSmeds.com
Background
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Study Approach
This was a randomized, double-blind, controlled study. The study was seeking participants with an average pain score between three and nine on the NPRS. Participants were randomly assigned to one of three groups: group one was treated with active NGX-4010 patches for 30 minutes, group two was treated with low concentration control patches for 30 minutes, group three was treated with active NGX-4010 patches for 60 minutes and group four was treated with low concentration control patches for 60 minutes.
Study Population
A total of 11 participants were recruited from five sites in Alberta, British Columbia, Manitoba, Ontario and Nova Scotia. There were no women enrolled for this trial.
Investigators
Here’s who is leading this study.
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