Potential for Improved Analgesia From Combined Medication for Superficial Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain Scores on Standardized Experimental Pain Testing
研究概览
简要总结
This research study is being done to assess if a combination of medications can enhance the relief of superficial pain (pain at the surface of the skin, such as sunburn pain). The investigators also want to find out if certain genes may be linked to individual differences in experienced efficacy of pain killers. The combination of medications under investigation is diclofenac and atropine. Diclofenac has been approved by the U.S. Food and Drug Administration (FDA) to treat pain. Atropine has been approved by the FDA to treat certain types of poisoning, heartbeat problems, and other diseases but atropine is not approved to treat pain. However, atropine has been used for many years in different European countries to treat painful conditions such as stomach cramps.This research study will compare diclofenac and atropine to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female healthy volunteers.
- •18-40 years of age.
- •Ability to read and understand English; English can be a second language provided that the participant feels that he/she understand all the questions used in the assessment measures.
排除标准
- •Chronic pain condition or chronic or current treatment with any pain medication.
- •Presence of any illness or medication use that is judged to interfere with the trial. For example: psychiatric disorder, medication that can influence cognition or emotional processing, i.e. sleep medication, antidepressants, anti-convulsants or opioids.
- •Unwillingness to receive brief pain stimulation administered by a heat probe on the hand.
- •Allergy or contra-indication to receiving nonsteroidal anti-inflammatory medication and atropine (Treatment with antidepressants, neuroleptics, antihistaminic, levodopa, anti-acids. Pregnancy, breast-feeding, myasthenia gravis, pyloric stenosis, gastro-esophageal reflux, gastric ulcer, constipation, prostatic enlargement, glaucoma, cardio-pulmonary condition -including tachycardia, arrhythmia, arteriosclerosis-, hyperthyroidism, high blood pressure, genetic disease, kidney failure)
研究组 & 干预措施
Pain medication: diclofenac and atropine
Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose
干预措施: Diclofenac and Atropine combination drug (Drug)
placebo
Placebo capsules will be delivered in same number as the medication
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Scores on Standardized Experimental Pain Testing
时间窗: baseline and 1 hour pain measurement
Pain scores on standardized experimental pain testing, with collection of Visual analog scales (VAS) on a 0-100 scale 0 (no pain)- 100 (worst pain imaginable) Higher values represent a worse outcome (more pain)
次要结局
- Catechol-O-methyltransferase (COMT) Polymorphism Correlation With Pain Relief(baseline and 1 hour pain measurement)
- Side Effects(baseline and 1 hour pain measurement)
研究者
Robert Edwards
Professor
Brigham and Women's Hospital