Clinical Management of Neuropathic Pain With Ramelteon
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Difference in Visual Analog Scale (VAS) for Pain (0-10) Between Treatments
研究概览
简要总结
This proposal is to conduct a double-blinded, randomized, placebo-controlled, crossover clinical study to examine the hypothesis that ramelteon would reduce pain score and improve functional status in subjects with neuropathic pain.
详细描述
Neuropathic pain is a chronic pain condition resulting from injury to the peripheral and/or central nervous system. Despite extensive research over the last several decades, neuropathic pain remains poorly managed due to the lack of effective pharmacological tools. To date, little has been known regarding the effect of melatonin and its analogues on clinical neuropathic pain. We propose to conduct a randomized, placebo-controlled, double-blinded, and crossover clinical trial to examine the effect of ramelteon [a melatonin (MT) 1/ MT2 receptor agonist] on neuropathic pain. We hypothesize that ramelteon would reduce pain score and improve functional status in subjects with neuropathic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Subject will be between ages 18 to 65 years.
- •Subject has not been on ramelteon for at least one month.
- •Subject agrees to make no change in his/her current pain medications during the entire study period (5 weeks). This requirement will ensure that valid comparisons of primary and secondary measures can be made before and after the study.
- •Subject has a VAS pain score of 5 or above at the beginning of the study.
- •Subject has had a neuropathic pain condition as listed above for at least three months. This requirement is to avoid clinical uncertainty from an unstable pain condition and to minimize the study variation.
- •Female subjects of childbearing potential must have a negative urine pregnancy test at the initial visit.
排除标准
- •Subject has moderate to severe liver impairment.
- •Subject has Liver Function Tests (LFT's) >1.5X normal.
- •Subject has a history of renal impairment.
- •Subject has moderate or severe cardiac or pulmonary disease including a base line oxygen saturation of less than 95% on room air or any requirement for supplemental oxygen.
- •Subject has a history of glaucoma.
- •Subject has obstructive sleep apnea.
- •Subject is taking medications for sleep disorders including insomnia.
- •Subject has a major psychiatric disorder (major depression requiring a recent hospitalization within three months prior to the study; bipolar disorder; schizophrenia; psychotic disorders; substance abuse).
- •Subject has a history of dementia or delirium.
- •Subject has a history of falls.
- •Subject is pregnant or lactating.
- •Subject is using an illicit drug detected by a screening test.
- •Subject is currently taking Fluvoxamine.
- •Subject has been taking Ketoconazole in the past two weeks.
- •Subject has known hypersensitivity to ramelteon.
- •Subject has pending litigation related to his/her neuropathic pain condition.
- •Subject has Concurrent participation in other research drug trials or other study participation within 30 days of enrollment in this study.
研究组 & 干预措施
Ramelteon first, placebo second
In a crossover design, a subject will be first assigned to the ramelteon arm and then switched over to the placebo arm. As this is a double-blind study, neither the subject nor the study staff will know which intervention the subject is randomly assigned. The ramelteon dose is 8mg once a night.The ramelteon and placebo will be blinded by the central pharmacy.
The subject is randomly assigned to first receive either ramelteon or placebo. The first intervention will be 14 days long. There is a 7 day washout period, and then the subject is assigned to the opposite intervention. The second intervention will be 14 days long.
干预措施: Ramelteon (Drug)
Ramelteon first, placebo second
In a crossover design, a subject will be first assigned to the ramelteon arm and then switched over to the placebo arm. As this is a double-blind study, neither the subject nor the study staff will know which intervention the subject is randomly assigned. The ramelteon dose is 8mg once a night.The ramelteon and placebo will be blinded by the central pharmacy.
The subject is randomly assigned to first receive either ramelteon or placebo. The first intervention will be 14 days long. There is a 7 day washout period, and then the subject is assigned to the opposite intervention. The second intervention will be 14 days long.
干预措施: Placebo (Drug)
Placebo first, ramelteon second
In a crossover design, a subject will be first assigned to the placebo arm and then switched over to the ramelteon arm. As this is a double-blind study, neither the subject nor the study staff will know which intervention the subject is randomly assigned. The ramelteon dose is 8mg once a night. The ramelteon and placebo will be blinded by the central pharmacy.
The subject is randomly assigned to first receive either ramelteon or placebo. The first intervention will be 14 days long. There is a 7 day washout period, and then the subject is assigned to the opposite intervention. The second intervention will be 14 days long.
干预措施: Ramelteon (Drug)
Placebo first, ramelteon second
In a crossover design, a subject will be first assigned to the placebo arm and then switched over to the ramelteon arm. As this is a double-blind study, neither the subject nor the study staff will know which intervention the subject is randomly assigned. The ramelteon dose is 8mg once a night. The ramelteon and placebo will be blinded by the central pharmacy.
The subject is randomly assigned to first receive either ramelteon or placebo. The first intervention will be 14 days long. There is a 7 day washout period, and then the subject is assigned to the opposite intervention. The second intervention will be 14 days long.
干预措施: Placebo (Drug)
结局指标
主要结局
Difference in Visual Analog Scale (VAS) for Pain (0-10) Between Treatments
时间窗: VAS score at baseline and after the treatment period
Subjects were asked to rate their pain the VAS with 0 being no pain and 10 being the worst pain they can imagine. The VAS scores were compared between the baseline and after a period of treatment. A negative number indicates an improvement in pain from baseline score.
次要结局
未报告次要终点
研究者
Jianren Mao, MD, PhD
Principal Investigator
Massachusetts General Hospital