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Completed

NCT Number: NCT01981395

Fenobam on Heat/Capsaicin Induced Hyperalgesia in Healthy Volunteers

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

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.

Other names: Lactose monohydrate

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Laura Cavallone

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Nov 11, 2013
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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