A Double-Blind, Placebo-Controlled, Randomized, Parallel Group Study to Assess Dopamine Receptor Modulation With Rotigotine to Enhance Opioid Analgesia Using the Oral Surgery Model of Acute Pain in Healthy Volunteers
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Sum of pain intensity difference scores
研究概览
简要总结
Narcotics are widely used as the mainstay of pain treatment, although increasing doses are required over time as the individual becomes tolerant to their effects. This can lead to the development of dependence and abuse of these drugs. Research has identified a new way to decrease the risk of developing tolerance to narcotics, by giving at the same time a drug called rotigotine ("Neupro"). Rotigotine interferes with the body's chemical dopamine and is FDA-approved for the management of Parkinson's Disease.
The purpose of this research study is to look at side effects and pain control in healthy people after removal of wisdom teeth, which usually causes pain. It is thought that by giving the study drug rotigotine with the narcotic pain reliever, there will be pain control that will extend longer than when giving the narcotic alone.
详细描述
Inclusion Criteria:
- Male and female patients aged 18 and over scheduled to undergo elective oral surgery for the removal of impacted third molars
- Indicated for the removal of 3-4 third molars, at least two of which are categorized as partial-boney or full-boney impactions
- Self-report of moderate or severe pain on a categorical scale with a minimum of 5 out of 10 on the numerical rating scale following the offset of local anesthesia
Exclusion Criteria:
- History or intolerance to rotigotine
- Current or history of mental disorder or substance abuse
- Allergy or intolerance to opioids or local anesthetics
- Concurrent or recent use of agents that may confound the sedative effects of the study drug (opioids, benzodiazepines) over the previous 7 days or alcohol ingestion in the previous 24 hours
- Chronic or recent use of medications that might confound the effects of rotigotine, e.g., antihistamines, prescription or over-the-counter NSAIDs (Nonsteroidal anti-inflammatory drugs), acetaminophen, steroids, antidepressants, muscle relaxants.
- Concurrent or history of chronic diseases, e.g., diabetes, rheumatoid arthritis, liver disease, cancer, hypertension or obesity (body mass index >35).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Male and female patients aged 18 and over scheduled to undergo elective oral surgery for the removal of impacted third molars
- •Indicated for the removal of 3-4 third molars, at least two of which are categorized as partial-boney or full-boney impactions
- •Self-report of moderate or severe pain on a categorical scale with a minimum of 5 out of 10 on the numerical rating scale following the offset of local anesthesia
排除标准
- •History or intolerance to rotigotine
- •Current or history of mental disorder or substance abuse
- •Allergy or intolerance to opioids or local anesthetics
- •Concurrent or recent use of agents that may confound the sedative effects of the study drug (opioids, benzodiazepines) over the previous 7 days or alcohol ingestion in the previous 24 hours
- •Chronic or recent use of medications that might confound the effects of rotigotine, e.g., antihistamines, prescription or over-the-counter NSAIDs, acetaminophen, steroids, antidepressants, muscle relaxants.
- •Concurrent or history of chronic diseases, e.g., diabetes, rheumatoid arthritis, liver disease, cancer, hypertension or obesity (body mass index >35).
研究组 & 干预措施
placebo patch
Neupro® transdermal patch/placebo randomly allocated like a flip of a coin applied to your skin at the dose of 8 mg/day or a matching placebo patch after the oral surgery procedure is completed.
干预措施: Neupro® transdermal patch/placebo (Drug)
Neupro® transdermal patch
Neupro® transdermal patch/placebo randomly allocated like a flip of a coin applied to your skin at the dose of 8 mg/day or a matching placebo patch after the oral surgery procedure is completed.
干预措施: Neupro® transdermal patch/placebo (Drug)
结局指标
主要结局
Sum of pain intensity difference scores
时间窗: up to six months
The primary outcome measure will be the SPID (sum of pain intensity difference scores) over the 3-hour observation period for MS(morphine sulfate)+Nuepro versus MS.
次要结局
- Analgesic tablets taken postoperatively(December 2014)
研究者
Raymond Dionne
Raymond A. Dionne, DDS, PhD Research Professor Department of Pharmacology & Toxicology Brody School of Medicine Department of Foundational Sciences School of Dental Medicine East Carolina University Greenville, NC 27834-4354
East Carolina University