Status:
COMPLETED
Effects of One Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Primary Insomnia
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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 es...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00368056
Start Date
April 1 2005
End Date
June 1 2006
Last Update
February 22 2012
Active Locations (1)
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1
HPRU Medical Research Centre, University of Surrey
Guildford, Surrey, United Kingdom