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

Primary Purpose

Primary Insomnia

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Eszopiclone
Placebo
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Insomnia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HPRU Medical Research Centre, University of Surrey

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

eszopiclone 3 mg

Placebo tablet

Outcomes

Primary Outcome Measures

next day performance in a standardised test of car driving

Secondary Outcome Measures

Compensatory Tracking Task (CTT)
Rapid Visual Information Processing (RVIP)
Sternberg's Short-term Memory Scanning task (STM)
Critical Flicker Fusion (CFF)
Digit Symbol Substitution Test (DSST)
Choice Reaction Time (CRT)
Leeds Sleep Evaluation Questionnaire and Leeds Analogue Rating Scales

Full Information

First Posted
August 23, 2006
Last Updated
February 21, 2012
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00368056
Brief Title
Effects of One Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
eszopiclone 3 mg
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo tablet
Intervention Type
Drug
Intervention Name(s)
Eszopiclone
Other Intervention Name(s)
S-Zopiclone, Lunesta
Intervention Description
eszopiclone 3 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet
Primary Outcome Measure Information:
Title
next day performance in a standardised test of car driving
Time Frame
9.5 hours post dose
Secondary Outcome Measure Information:
Title
Compensatory Tracking Task (CTT)
Time Frame
9.5 hours post dose
Title
Rapid Visual Information Processing (RVIP)
Time Frame
9.5 hours post dose
Title
Sternberg's Short-term Memory Scanning task (STM)
Time Frame
9.5 hours post dose
Title
Critical Flicker Fusion (CFF)
Time Frame
9.5 hours post dose
Title
Digit Symbol Substitution Test (DSST)
Time Frame
9.5 hours post dose
Title
Choice Reaction Time (CRT)
Time Frame
9.5 hours post dose
Title
Leeds Sleep Evaluation Questionnaire and Leeds Analogue Rating Scales
Time Frame
9.5 hours post dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
HPRU Medical Research Centre, University of Surrey
City
Guildford
State/Province
Surrey
Country
United Kingdom

12. IPD Sharing Statement

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

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