Hyperalgesia Clinical Trial
Official title:
A Double Blind, Randomized, Placebo Controlled, Crossover Study to Investigate the Anti-hyperalgesic Efficacy of a Single Dose of Fenobam on Heat/Capsaicin Induced Cutaneous Hyperalgesia in Adult Healthy Volunteers.
Our goal is to demonstrate that healthy volunteers treated with fenobam will develop a significantly reduced area of cutaneous hyperalgesia compared to volunteers treated with placebo, after exposure to the heat/capsaicin model of cutaneous sensitization. Additionally we are going to assess changes in mood/affect and cognitive function of subjects following administration of fenobam and after cutaneous sensitization compared to baseline.
All subjects will receive a topical dose of capsaicin cream 0.1%(Capzasin-HP) to the forearm
at the start of the study visit. The order of the 2 treatment regimens indicated below will
be randomized and blinded to subjects and researchers.
Treatment Regimen 1: Fenobam [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine)
urea hydrate]: administration of one 150 mg gelatin capsule.
Treatment Regimen 2: Placebo (lactose monohydrate): administration of one 150 mg gelatin
capsule.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
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