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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01981395
• Other study ID #: 201311094
• Status: Completed
• Phase: Phase 1
• First received: November 4, 2013
• Last updated: April 27, 2016
• Start date: January 2014
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Allodynia
• Hyperalgesia

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Laura Cavallone

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suppression of the development of cutaneous hyperalgesia and allodynia around the area treated with heat/capsaicin.	size of the area of hyperalgesia and allodynia around the area sensitized by heat/capsaicin as quantified by cutaneous stimulation with foam brush strokes and a von Frey filament requiring 26 g of bending force.	During approximately 7 hours of consecutive assessments	No
Secondary	Evaluation of nociception after drug administration as evaluated by prolonged (1 min) thermal stimulation on normal (untreated) skin.	Visual Analog Scale (VAS) rating of pain perception at 1 min 45°C heat stimulation on normal skin.	During approximately 7 hours of consecutive assessments	No
Secondary	Assessment of Heat Pain Detection Thresholds (HPDT) in normal and sensitized skin pre and post treatment with fenobam.	lowest temperature perceived as painful with stimulation starting at 32°C and with a safety cut-off at 52°C.	During approximately 7 hours of consecutive assessments	No
Secondary	Absence of significant side effects	Determined by subjects' monitoring during treatment sessions and follow up at 1 day and 1 week after treatment with drug.	7 days	Yes
Secondary	Assessment of significant change in mood/affect	As determined by evaluation of the subjects by combined brief Positive And Negative Affect Scale/Brief State Anxiety Measure (PANAS/BSAM)	During approximately 6 hours of consecutive assessments	No
Secondary	Assessment of significant change in cognitive function	As determined by evaluation of the Letter and Number Sequencing (LNS) assessment	During approximately 6 hours of consecutive assessments	Yes