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

NCT ID: NCT00368056

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2006-06-30

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.

Conditions

Primary Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

eszopiclone 3 mg

Group Type: EXPERIMENTAL

Eszopiclone

Intervention Type: DRUG

eszopiclone 3 mg

2

Placebo tablet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet

Interventions

Eszopiclone

eszopiclone 3 mg

Intervention Type: DRUG

Placebo

Placebo tablet

Intervention Type: DRUG

Other Intervention Names

S-Zopiclone; Lunesta

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HPRU Medical Research Centre, University of Surrey

Guildford, Surrey, United Kingdom

Countries

United Kingdom

Other Identifiers

190-060

Identifier Type: -

Identifier Source: org_study_id