Fenobam on Heat/Capsaicin Induced Hyperalgesia in Healthy Volunteers

Sponsor

Laura Cavallone (Other)

Overall Status

Completed

CT.gov ID

NCT01981395

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperalgesia Allodynia	Drug: Fenobam Drug: Placebo	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

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.

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment regimn 1 150 mg Fenobam Orally - once	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. Other Names: [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate]
Placebo Comparator: Treatment Regimen 2 Placebo orally - once	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. Other Names: Lactose monohydrate

Arm

Intervention/Treatment

Experimental: Treatment regimn 1

150 mg Fenobam Orally - once

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.

Other Names:

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

Placebo Comparator: Treatment Regimen 2

Placebo orally - once

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.

Other Names:

Lactose monohydrate

Outcome Measures

Primary Outcome Measures

Suppression of the development of cutaneous hyperalgesia and allodynia around the area treated with heat/capsaicin. [During approximately 7 hours of consecutive assessments]
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.

Secondary Outcome Measures

Evaluation of nociception after drug administration as evaluated by prolonged (1 min) thermal stimulation on normal (untreated) skin. [During approximately 7 hours of consecutive assessments]
Visual Analog Scale (VAS) rating of pain perception at 1 min 45°C heat stimulation on normal skin.
Assessment of Heat Pain Detection Thresholds (HPDT) in normal and sensitized skin pre and post treatment with fenobam. [During approximately 7 hours of consecutive assessments]
lowest temperature perceived as painful with stimulation starting at 32°C and with a safety cut-off at 52°C.
Absence of significant side effects [7 days]
Determined by subjects' monitoring during treatment sessions and follow up at 1 day and 1 week after treatment with drug.
Assessment of significant change in mood/affect [During approximately 6 hours of consecutive assessments]
As determined by evaluation of the subjects by combined brief Positive And Negative Affect Scale/Brief State Anxiety Measure (PANAS/BSAM)
Assessment of significant change in cognitive function [During approximately 6 hours of consecutive assessments]
As determined by evaluation of the Letter and Number Sequencing (LNS) assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18-50 year old
Good general health with no remarkable medical conditions (e.g. liver, kidney, heart, or lung failure)
BMI between 20-33
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]
Willing to provide informed consent

Exclusion Criteria:

Anatomical malformation of upper extremities
Status post recent trauma or chronic lesions on either forearm
Medication use (includes vitamin, herbal, dietary and mineral supplements and grapefruit products during or within 14 days prior to study participation; excludes contraceptives)
History of allergy or intolerance to capsaicin
History of multiple drug allergies
History of addiction to drugs or alcohol (prior or present addiction or treatment for addiction)
History of chronic pain syndromes
Pregnant and nursing females
Smokers