Fenobam on Heat/Capsaicin Induced Hyperalgesia in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT01981395|
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : April 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hyperalgesia Allodynia||Drug: Fenobam Drug: Placebo||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|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 :||January 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||April 2016|
Experimental: Treatment regimn 1
150 mg Fenobam Orally - once
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 Name: [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate]
Placebo Comparator: Treatment Regimen 2
Placebo orally - once
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 Name: Lactose monohydrate
- Suppression of the development of cutaneous hyperalgesia and allodynia around the area treated with heat/capsaicin. [ Time Frame: 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.
- Evaluation of nociception after drug administration as evaluated by prolonged (1 min) thermal stimulation on normal (untreated) skin. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: During approximately 6 hours of consecutive assessments ]As determined by evaluation of the Letter and Number Sequencing (LNS) assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981395
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Laura F Cavallone, M.D.||Washington University School of Medicine|