EUCTR2004-004350-91-DE进行中（未招募）1 期
A multicentre, randomised, double-blind, double-dummy, placebo-controlled study to evaluate the safety and efficacy of ramelteon compared to placebo with zopiclone as a reference arm in adults with chronic insomnia
Takeda Global R&D Centre (Europe)0 个研究点目标入组 275 人开始时间: 2006年5月5日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 275
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The subject is a male or female 18 to 64 years of age, inclusive.
- •The subject is capable of understanding and willing to comply with the protocol and has signed the informed consent document at screening prior to any study related procedures being performed.
- •Study-specific
- •The subject, if female, is non-pregnant and non-lactating. Females of childbearing potential must use appropriate birth control (barrier methods, hormonal contraceptives, and/or intrauterine devices) for the entire duration of the study. Females who are not of childbearing potential must be postmenopausal for 1 year or have a history of hysterectomy and/or bilateral oophorectomy.
- •Based on sleep history, the subject has had chronic insomnia as defined by the following:
- •A complaint is difficulty initiating or maintaining sleep or of nonrestorative sleeps that lasts for at least 3 months.
- •The sleep disturbance (or associated daytime fatigue) causes clinically significant distress or impairment in social, occupational, or other important areas of functioning.
- •The disturbance does not occur exclusively during the course of Narcolepsy, Breathing-Related Sleep Disorder, Circadian Rhythm Sleep Disorder or a Parasomnia.
- •The subject’s sleep disturbance does not occur exclusively during the course of another mental disorder (eg, Major Depressive Disorder, Generalised Anxiety Disorder, a delirium).
- •The disturbance is not due to the direct physiological effects of a substance (eg, a drug of abuse, a medication) or a general medical condition.
- •Based on sleep history, the subjects reports history sSL greater than or equal to 45 minutes, and sTST less than or equal to 6.5 hours.
- •The subject has mean LPS of =20 minutes on two consecutive screening nights with neither night less than 15 minutes.
- •The subject’s habitual bedtime is between 10:00 p.m. and 1:00 a.m.
- •Subjects should be able to stand with eyes closed, arms at side and feet apart at hips width for at least one minute with out taking a step.
- •The subject has a body mass index (BMI) between 18 and 34, inclusive.
- •* Based on sleep history, the subject uses pharmacological assistance to sleep 0 to 4 times per week in the last 3 months. Subject must agree to discontinue use of all pharmacological sleep aids beginning one week prior to the dose of single-blind study medication and throughout the entire duration of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects with a history of psychiatric disorder, or alcohol / drug abuse within the last 12 months.
- •The subject uses tobacco products during nightly awakenings.
- •The subject has a known hypersensitivity to ramelteon, zopiclone or related compounds, including melatonin.
- •The subject has any additional condition(s) that in the Investigator’s opinion would: a) affect sleep/wake function, b) prohibit the subject from completing the study, or c) not be in the best interest of the subject.
- •Study-specific
- •The subject has participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first night of single-blind study medication, whichever is longer.
- •The subject has sleep schedule changes required by employment (e.g. shift worker) within three months prior to the first night of single-blind study medication, or has flown across greater than three time zones within seven days prior to screening.
- •Subject has a history of or currently has conditions that would affect balance such as orthostatic hypotension, dizziness, vertigo, or benign paraoxysmal positional vertigo (BPPV).
- •The subject has ever had a history of seizures; sleep apnoea, COPD, restless leg syndrome (RLS), periodic leg movement syndrome (PLMS), or fibromyalgia.
- •The subject has a history of psychiatric disorder (including anxiety, depression, mental retardation, cognitive disorder, bipolar illness and schizophrenia) within the past 6 months.
- •The subject has a history of drug addiction or drug abuse within the past 12 months.
- •The subject has a history of alcohol abuse within the past 12 months, as defined in DSM-IV-TR TM, or regularly consumes more than 14 alcoholic drinks per week, or consumed any alcoholic drinks within 24 hours of all PSG visits.
- •The subject has a current significant neurological (including cognitive and psychiatric disorders), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, haematological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication 30 days prior to the first night of single blind study medication.
- •The subject has used melatonin, or other drugs or supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug, whichever is longer) prior to the first day of single-blind study medication.
- •The subject has used any central nervous system medication within 1 week (or 5 half lives of the drug, whichever is longer) prior to the first day of single-blind study medication.
- •The subject has a positive urine drug screen including alcohol at screening or a positive breathalyser test at each check-in.
- •The subject has an apnoea hypopnoea index (per hour of sleep) >10 as seen on PSG, on the first night of the PSG screening.
- •The subject has periodic leg movement (PLM) with arousal index (per hour of sleep) >10 as seen on PSG, on the first night of PSG screening.
- •Subjects who have lower limb prosthetics.
- •* The subject has participated in a weight loss program or has substantially altered their exercise routine witihin 30 days prior to the first night of single-blind study medication.
- •* The subject intends to continue taking any disallowed medication or any prescription medication, over-the-counter (OTC) or herbal medication that is known to affect the sleep/wake function or otherwise interfere with evaluation of the study medication. The subject must rep
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