Fenobam on Heat/Capsaicin Induced Hyperalgesia in Healthy Volunteers

NCT ID: NCT01981395

Last Updated: 2016-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-04-30

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.

Conditions

Hyperalgesia; Allodynia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Study Groups

Treatment regimn 1

150 mg Fenobam Orally - once

Group Type: EXPERIMENTAL

Fenobam

Intervention Type: DRUG

Fenobam 150 mg will be administered and subjects will be monitored for up to 8 hours. During the study day questionnaires will be administered, blood will be drawn a testing site will be marked and pain testing and heat/capsaicin sensitization will be measured.

Treatment Regimen 2

Placebo orally - once

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

A placebo will be administered and subjects will be monitored for up to 8 hours. During the study day questionnaires will be administered, blood will be drawn a testing site will be marked and pain testing and heat/capsaicin sensitization will be measured.

Interventions

Fenobam

Fenobam 150 mg will be administered and subjects will be monitored for up to 8 hours. During the study day questionnaires will be administered, blood will be drawn a testing site will be marked and pain testing and heat/capsaicin sensitization will be measured.

Intervention Type: DRUG

Placebo

A placebo will be administered and subjects will be monitored for up to 8 hours. During the study day questionnaires will be administered, blood will be drawn a testing site will be marked and pain testing and heat/capsaicin sensitization will be measured.

Intervention Type: DRUG

Other Intervention Names

[1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate]; Lactose monohydrate

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laura Cavallone

OTHER

Sponsor Role: lead

Responsible Party

Laura Cavallone

Assistant Professor of Anesthesiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Laura F Cavallone, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

201311094

Identifier Type: -

Identifier Source: org_study_id