- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00368056
Effects of One Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability
February 21, 2012 updated by: Sunovion
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
To assess next day driving ability and psychomotor/memory function following a single night time dose of eszopiclone in insomnia patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
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.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Surrey
-
Guildford, Surrey, United Kingdom
- HPRU Medical Research Centre, University of Surrey
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
eszopiclone 3 mg
|
eszopiclone 3 mg
Other Names:
|
Placebo Comparator: 2
Placebo tablet
|
Placebo tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
next day performance in a standardised test of car driving
Time Frame: 9.5 hours post dose
|
9.5 hours post dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compensatory Tracking Task (CTT)
Time Frame: 9.5 hours post dose
|
9.5 hours post dose
|
Rapid Visual Information Processing (RVIP)
Time Frame: 9.5 hours post dose
|
9.5 hours post dose
|
Sternberg's Short-term Memory Scanning task (STM)
Time Frame: 9.5 hours post dose
|
9.5 hours post dose
|
Critical Flicker Fusion (CFF)
Time Frame: 9.5 hours post dose
|
9.5 hours post dose
|
Digit Symbol Substitution Test (DSST)
Time Frame: 9.5 hours post dose
|
9.5 hours post dose
|
Choice Reaction Time (CRT)
Time Frame: 9.5 hours post dose
|
9.5 hours post dose
|
Leeds Sleep Evaluation Questionnaire and Leeds Analogue Rating Scales
Time Frame: 9.5 hours post dose
|
9.5 hours post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
August 23, 2006
First Submitted That Met QC Criteria
August 23, 2006
First Posted (Estimate)
August 24, 2006
Study Record Updates
Last Update Posted (Estimate)
February 22, 2012
Last Update Submitted That Met QC Criteria
February 21, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 190-060
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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