Fenobam on Heat/Capsaicin Induced Hyperalgesia in Healthy Volunteers

Laura Cavallone

Status and phase: Completed; Phase 1

Conditions: Hyperalgesia; Allodynia

Treatments: Drug: Fenobam; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01981395

201311094

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

33 participants in 2 patient groups, including a placebo group

Treatment regimn 1

Experimental group

Description:

150 mg Fenobam Orally - once

Treatment:

Drug: Fenobam

Treatment Regimen 2

Placebo Comparator group

Description:

Placebo orally - once

Treatment:

Drug: Placebo