EUCTR2005-000120-17-GB进行中（未招募）1 期
A double-blind placebo-controlled cross-over study to determine if melatonin can improve the length of day time sleep in subjects with transient misalignment of the sleep-wake cycle as a result of working permanent night shifts.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •1.Male or female subjects aged 18-65 working permanent night shifts with at least 3 consecutive night shifts in their shift pattern.
- •A female subject may be included if:
- •She is of non-child-bearing potential (e.g. post-menopausal for one year, had bilateral tubal ligation, had a hysterectomy or is physiologically incapable of becoming pregnant), or
- •She is of childbearing potential practicing an acceptable method of birth control defined as the use of oral or depot hormonal contraception, an intrauterine contraceptive device or a combination of both spermicidal and barrier methods of contraception. A partner having had a vasectomy is not an acceptable reason for inclusion, or
- •Total abstinence from sexual intercourse is maintained.
- •2.Written informed consent.
- •3.No planned absences from work, other than rest days, for the duration the subject will be in 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
- •1.Have a clinically significant unstable medical abnormality, chronic disease or history or presence of significant neurological, hepatic, renal, endocrine, cardiovascular, GI, pulmonary, psychiatric, metabolic disease or malignancy or other clinically relevant abnormality which in the opinion of the investigator would preclude successful participation in the study.
- •2.Have a recent history of (< 2 years) alcohol or drug abuse or current evidence of substance dependence or abuse as defined by DSM-IV criteria (see Appendix VII).
- •3.Female subjects who are pregnant or not using an adequate form of contraception or who are breast-feeding.
- •4.Subjects receiving vitamins B6 and B12 supplements (excluding multivitamin supplements at recommended dose).
- •5.Subjects with a known hypersensitivity to melatonin or any of the excipients in the formulation. Excipients include: lactose, Methocel (methylcellulose), Aerosil (colloidal silicon dioxide), magnesium stearate, Opadry II (colourant).
- •6.Subjects receiving tricyclic antidepressants, monoamine oxidase inhibitors, serotonin re-uptake inhibitors, lithium, beta-blockers, calcium channel blockers, central alpha-blockers, non-steroidal anti-inflammatory agents (excluding occasional use of OTC NSAIDs), alprazolam, triazolam, neuroleptics, and barbiturates. Subjects currently receiving any of these compounds are eligible for entry provided the medication is stopped 2 weeks prior to study entry.
- •7.Subjects with a known history of impaired hepatic or renal function defined as transaminases > 2X the upper limit of normal or creatinine clearance of <35ml/min.
- •8.Subjects with a known severe allergic or auto-immune disease (e.g. multiple sclerosis, rheumatoid arthritis, severe asthma and systemic lupus erythematosus).
- •9.Subjects who have received an experimental drug within the previous 3 months.
- •10.Subjects who use melatonin.
- •11.Subjects, who, by virtue of the need to care for close family members, may be subjected to intermittent disturbance during their daytime rest periods.
- •12.Subjects who, in the opinion of the investigator, are not capable of completing the study.
研究者
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