Fenobam on Heat/Capsaicin Induced Hyperalgesia in Healthy Volunteers

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.

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Allodynia
• Hyperalgesia

• NCT number: NCT01981395
• Study type: Interventional
• Source: Washington University School of Medicine
• Status: Completed
• Phase: Phase 1
• Start date: January 2014
• Completion date: April 2016