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Study of an Evening Dose of Eszopiclone on Next Day Driving Ability & Psychomotor/Memory Function in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00368160
First Posted: August 24, 2006
Last Update Posted: February 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sunovion
August 23, 2006
August 24, 2006
February 22, 2012
March 2004
July 2005   (Final data collection date for primary outcome measure)
next day performance in a standardised test of car driving [ Time Frame: 9.5 hours post dose ]
Not Provided
Complete list of historical versions of study NCT00368160 on ClinicalTrials.gov Archive Site
  • Compensatory Tracking Task (CTT) [ Time Frame: 9.5 hours post dose ]
  • Rapid Visual Information Processing (RVIP) [ Time Frame: 9.5 hours post dose ]
  • Sternberg's Short-term Memory Scanning task (STM) [ Time Frame: 9.5 hours post dose ]
  • Critical Flicker Fusion (CFF) [ Time Frame: 9.5 hours post dose ]
  • Digit Symbol Substitution Test (DSST) [ Time Frame: 9.5 hours post dose ]
  • Choice Reaction Time (CRT) [ Time Frame: 9.5 hours post dose ]
  • Leeds Sleep Evaluation Questionnaire and Leeds Analogue Rating Scales [ Time Frame: 9.5 hours post dose ]
Not Provided
Not Provided
Not Provided
 
Study of an Evening Dose of Eszopiclone on Next Day Driving Ability & Psychomotor/Memory Function in Healthy Volunteers
The Effects of a Single Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability and Psychomotor/Memory Function in Healthy Volunteers Compared to Placebo
Male and female healthy volunteers. Patients must also possess a full current driving license (for at least one year), and be a regular car driver.
The study is a single centre, randomised, double blind, placebo controlled 2-way crossover design in a group of 32 healthy male and female volunteers. The medications under investigation are eszopiclone and placebo. Volunteers 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. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Insomnia
  • Drug: Eszopiclone
    eszopiclone 3 mg
    Other Names:
    • S-Zopiclone
    • Lunesta
  • Drug: Placebo
    Placebo tablet
  • Experimental: 1
    eszopiclone 3 mg
    Intervention: Drug: Eszopiclone
  • Placebo Comparator: 2
    Placebo tablet
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2005
July 2005   (Final data collection date for primary outcome measure)

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
  • 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

  • Clinically significant use of psychotropic medication in the last three months. For example, this would include the prolonged use of antidepressants, antipsychotics, or antihistamines, but would exclude the occasional use of cold or flu remedies (which often contain antihistamines and/ or opiates)
  • The use of any other medication in the last two weeks with the exception of oral, transdermal, IUDs (progestogen only contraceptive e.g. Mirena), or depot contraceptives, non-steroidal analgesics (e.g. ibuprofen), and paracetamol
  • 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 (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
  • Volunteers 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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00368160
190-059
No
Not Provided
Not Provided
Sunovion
Sunovion
Not Provided
Not Provided
Sunovion
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP