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.
- Conditions
- Transient misalignment of the sleep-wake cycle as a result of working night shifts (insomnia in night shift workers)
- Registration Number
- EUCTR2005-000120-17-GB
- Lead Sponsor
- Alliance Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 60
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine if the administration of 1.5mg APL510 can increase the length of daytime sleep following a night shift. <br>;Secondary Objective: 1.To determine if the administration of 1.5mg APL510 can increase the maintenance of daytime sleep and reduce sleep latency and the number of episodes of disturbed sleep following a night shift.<br><br>2.To determine if the use of 1.5mg APL510 has any ‘hang-over’ effect during the night shift work period.<br><br>3.To compare the adverse event profiles of APL510 and placebo.;Primary end point(s): The primary measure of efficacy will be a change in the subjects’ total sleep time.
- Secondary Outcome Measures
Name Time Method