Fenobam on Heat/Capsaicin Induced Hyperalgesia in Healthy Volunteers
Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperalgesia; Allodynia
Intervention: Fenobam (Drug); Placebo (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Laura Cavallone Official(s) and/or principal investigator(s):
Laura F Cavallone, M.D., Principal Investigator, Affiliation: Washington University School of Medicine
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: Suppression of the development of cutaneous hyperalgesia and allodynia around the area treated with heat/capsaicin.
Secondary outcome: Evaluation of nociception after drug administration as evaluated by prolonged (1 min) thermal stimulation on normal (untreated) skin.Assessment of Heat Pain Detection Thresholds (HPDT) in normal and sensitized skin pre and post treatment with fenobam. Absence of significant side effects Assessment of significant change in mood/affect Assessment of significant change in cognitive function
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
Washington University School of Medicine, St. Louis, Missouri 63110, United States
Additional Information
Starting date: January 2014
Last updated: June 3, 2015
|
