Effects of One Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability - Tabular View

Tracking Information
First Received Date ^ICMJE	August 23, 2006
Last Updated Date	October 9, 2008
Start Date ^ICMJE	April 2005
Primary Completion Date	June 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 6, 2008)	next day performance in a standardised test of car driving [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00368056 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 6, 2008)	Compensatory Tracking Task (CTT) [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ] Rapid Visual Information Processing (RVIP) [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ] Sternberg's Short-term Memory Scanning task (STM) [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ] Critical Flicker Fusion (CFF) [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ] Digit Symbol Substitution Test (DSST) [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ] Choice Reaction Time (CRT) [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ] Leeds Sleep Evaluation Questionnaire and Leeds Analogue Rating Scales [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Effects of One Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability
Official Title ^ICMJE	Effects of a Single Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability and Psychomotor/Memory Function in Patients With Primary Insomnia Compared to Placebo
Brief Summary	To assess next day driving ability and psychomotor/memory function following a single night time dose of eszopiclone in insomnia patients.
Detailed Description	The study is a single centre, randomised, double blind, placebo controlled 2-way crossover design in a group of 32 male and female primary insomnia patients. The medications under investigation are eszopiclone and placebo. Patients will receive the study medications and placebo on the evening of Day 2 of each treatment period. Performance will be assessed on Day 3 of each treatment period. Each treatment period will be separated by at least a 7-day washout period.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Safety Study
Condition ^ICMJE	Primary Insomnia
Intervention ^ICMJE	Drug: Eszopiclone Drug: Placebo
Study Arms / Comparison Groups	Experimental: eszopiclone 3 mg Placebo Comparator: Placebo tablet
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	32
Completion Date	June 2006
Primary Completion Date	June 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Aged between 18 and 55 years inclusive In good health as determined by a medical history, ECG, haematology, blood and urine biochemistry and physical examination by the doctor Diagnostic and statistical manual of mental disorders, defined primary insomnia A body mass index greater than or equal to 18 and less than or equal to 30 Registered with a general practitioner (GP) Hold a full current driving licence for at least one year, and be regular car drivers Exclusion Criteria The use of any other medication during the study with the exception of oral, transdermal, IUDs (progestogen only contraceptive e.g. Mirena), or depot contraceptives, non-steroidal analgesics (e.g. ibuprofen), and paracetamol. A 7-day washout period is required for any patient currently receiving prescription or non-prescription sleep medication. Diagnosed sleep disorder or confirmed symptoms other than primary insomnia (e.g. restless leg syndrome, sleep apnoea) Significant history of mental illness, significant drug allergy, malignancy or chronic drug abuse (including alcohol) Any subject with known hypersensitivity to any of the study treatments A sleep/wake cycle other than primary insomnia (e.g. shift work) liable to prejudice the results of the study Pregnant or lactating females, and females of child bearing potential not using effective contraception Patients who habitually smoke more than 5 cigarettes per day Caffeine consumption of more than 5 cups or glasses per day History of alcohol or drug dependence or intake of more than the equivalent of 14 units of alcohol per week for females and 21 units per week for males Current participation in another clinical trial, or participation in a clinical trial within the last 90 days
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00368056
Responsible Party	Eszopiclone Medical Director, Sepracor Inc.
Study ID Numbers ^ICMJE	190-060
Study Sponsor ^ICMJE	Sepracor, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Sepracor, Inc.
Verification Date	October 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP