Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-24 @ 1:21 PM
NCT ID:
NCT01981395
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT01981395
Study Brief:
Protocol Section:
NCT01981395