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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment regimn 1 | Experimental | 150 mg Fenobam Orally - once |
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| Treatment Regimen 2 | Placebo Comparator | Placebo orally - once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenobam | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Assessment of Heat Pain Detection Thresholds (HPDT) in normal and sensitized skin pre and post treatment with fenobam. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura F Cavallone, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C032794 | fenobam |
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|
| Placebo | 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. |
|
|
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 |
| 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 |
| 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 |
| 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |