Effect of NGX-4010 on ENFD and Sensory Function
|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)|
|Estimated 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|
|Estimated 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.
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|