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

Information source: Sunovion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Insomnia

Intervention: Eszopiclone (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sunovion

Summary

To assess next day driving ability and psychomotor/memory function following a single night time dose of eszopiclone in insomnia patients.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: next day performance in a standardised test of car driving

Secondary outcome:

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Locations and Contacts

HPRU Medical Research Centre, University of Surrey, Guildford, Surrey, United Kingdom
Additional Information

Starting date: April 2005
Last updated: February 21, 2012

Page last updated: August 23, 2015

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