A DOUBLE-BLIND, PARALLEL GROUP, RANDOMISED, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CIRCADIN® 2MG IN THE IMPROVEMENT OF SLEEP QUALITY IN PATIENTS WITH INSOMNIA AGED 55-80 YEARS.

eurim Pharmaceuticals (1991) Ltd0 个研究点目标入组 520 人开始时间: 2005年2月14日最近更新: 2019年11月25日

研究概览

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•· male or female and aged 55-80 years
•· suffering from primary insomnia according to DSM-IV criteria (307.42 primary
•insomnia, Appendix 24.3) characterized by poor quality of sleep with or without
•difficulty in initiating sleep or difficulty in maintaining sleep (Based on a Sleep
•History Questionnaire that is given to the patient before Visit 1, Appendix 24.11)
•· have not been using BZD and non-BZD hypnotics for the past 2 weeks or more
•· have not been using psychotropic treatments for the past 3 months or more
•· are stabilized on non-psychotropic treatments for more than 3 months
•· are willing to take a 6-SMT level evaluation test on the night of the visit
•· are willing to sign a written informed consent to participate in the study
•Patients completing the two week placebo run-in and who fulfil the following criteria will be eligible to be randomised:
•· Negative drug screen (BZD and opiates)
•· No reported use of BZD and non-BZD hypnotics, antihistamines or psychotropic
•treatments during the two-week placebo run-in period
•· A good compliance during the two-week placebo run-in period defined as 70% to
•130% of prescribed tablets
•· Correct use of the LSEQ and Sleep Diary
•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) yes
•F.1.3.1 Number of subjects for this age range

•· Incorrect use of the Sleep Diary or of the Leeds questionnaire.
•· Use of benzodiazepines or other hypnotics (including psychotropic treatments) during the study and preceding two weeks.
•· Alcohol intake more than 30 g of pure alcohol per day and any intake after lunch-time.
•· Pharmacological immunosuppression
•· Participation in a clinical trial with any investigational agent within two months prior
•to study enrollment
•· According to DSM IV, subjects belonging to the following groups are excluded:
•780.59 (breathing related sleep disorder);
•307.45 (circadian rhythm sleep disorder);
•307.47 (dyssomnia not otherwise specified);
•780.xx (sleep disorder due to general medical condition)
•· Severe neurological, psychiatric disorders and alcoholism
•· Other serious diseases that could interfere with patient assessment

发起方

eurim Pharmaceuticals (1991) Ltd