Fenobam on Heat/Capsaicin Induced Hyperalgesia in Healthy Volunteers

NCT01981395 | Completed Phase 1 DMC

• 1 other identifier: 201311094
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperalgesia; Allodynia

Keywords

fenobam; heat; capsaicin; hyperalgesia; allodynia; mood; cognitive function

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

• 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

• Absence of significant side effects

  7 days

• Assessment of significant change in mood/affect

  During approximately 6 hours of consecutive assessments

• Assessment of significant change in cognitive function

  During approximately 6 hours of consecutive assessments

Study Arms (2)

Treatment regimn 1

EXPERIMENTAL

150 mg Fenobam Orally - once

Drug: Fenobam

Treatment Regimen 2

PLACEBO COMPARATOR

Placebo orally - once

Drug: Placebo

Interventions

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.

Also known as: [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate]

Treatment regimn 1

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.

Also known as: Lactose monohydrate

Treatment Regimen 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laura Cavallone: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Hyperalgesia

Interventions

fenobam

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura F Cavallone, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 11, 2013
• Study Start: January 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: April 1, 2016
• Last Updated: April 29, 2016

Record last verified: 2016-04

Locations

US (1)