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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
Sponsor:
Information provided by (Responsible Party):
Laura Cavallone, Washington University School of Medicine

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 Type : Interventional  (Clinical Trial)
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 : January 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

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 Name: [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 Name: Lactose monohydrate




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Laura Cavallone
Investigators
Principal Investigator: Laura F Cavallone, M.D. Washington University School of Medicine

Responsible Party: Laura Cavallone, Assistant Professor of Anesthesiology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01981395     History of Changes
Other Study ID Numbers: 201311094
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016

Keywords provided by Laura Cavallone, Washington University School of Medicine:
fenobam
heat
capsaicin
hyperalgesia
allodynia
mood
cognitive function

Additional relevant MeSH terms:
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs