Effect of NGX-4010 on ENFD and Sensory Function
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|ClinicalTrials.gov Identifier: NCT00254449|
Recruitment Status : Completed
First Posted : November 16, 2005
Last Update Posted : February 16, 2009
|Condition or disease||Intervention/treatment||Phase|
|Human Volunteers||Drug: NGX-4010||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Controlled, Open-Label Study to Investigate the Effect of NGX-4010 on Epidermal Nerve Fiber Density and Sensory Function in Healthy Volunteers|
|Study Start Date :||November 2005|
|Study Completion Date :||May 2006|
- Mean ENFD in the patch-treated and comparable untreated skin areas (control) at 1, 12 and 24 weeks after exposure.
- Mean just noticeable difference (JND) values for thermal perception QST in the patch-treated and comparable untreated skin areas (control) at 1, 12 and 24 weeks after exposure.
- Mean difference in mechanical (sharp pain) sensation and tactile threshold between patch-treated and comparable untreated skin areas (control) at 1, 12 and 24 weeks after exposure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254449
|United States, Minnesota|
|NeurogesX Investigational Site|
|Minneapolis, Minnesota, United States, 55455|
|Study Director:||Jeffrey Tobias, MD||NeurogesX|
|Principal Investigator:||William R. Kennedy, MD||University of Minnesota - Clinical and Translational Science Institute|