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.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Suppression of the development of cutaneous hyperalgesia and allodynia around the area treated with heat/capsaicin.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment regimn 1
150 mg Fenobam Orally - once
干预措施: Fenobam (Drug)
Treatment Regimen 2
Placebo orally - once
干预措施: Placebo (Drug)
结局指标
主要结局
Suppression of the development of cutaneous hyperalgesia and allodynia around the area treated with heat/capsaicin.
时间窗: 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.
次要结局
- 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)
研究者
Laura Cavallone
Assistant Professor of Anesthesiology
Washington University School of Medicine