Fenobam on Heat/Capsaicin Induced Hyperalgesia in Healthy Volunteers



Status:Completed
Conditions:Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 50
Updated:3/16/2015
Start Date:January 2014
End Date:January 2016
Contact:Karen Frey
Email:freyk@anest.wustl.edu
Phone:314-454-5980

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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.

Inclusion Criteria:

1. 18-50 year old

2. Good general health with no remarkable medical conditions (e.g. liver, kidney,
heart, or lung failure)

3. BMI between 20-33

4. Willing to comply with study guidelines as outlined in protocol [including: women of
childbearing age must be willing to use a double-barrier method (e.g. oral
contraception and condom) for contraception during participation in the study]

5. Willing to provide informed consent

Exclusion Criteria:

1. Anatomical malformation of upper extremities

2. Status post recent trauma or chronic lesions on either forearm

3. Medication use (includes vitamin, herbal, dietary and mineral supplements and
grapefruit products during or within 14 days prior to study participation; excludes
contraceptives)

4. History of allergy or intolerance to capsaicin

5. History of multiple drug allergies

6. History of addiction to drugs or alcohol (prior or present addiction or treatment for
addiction)

7. History of chronic pain syndromes

8. Pregnant and nursing females

9. Smokers
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
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