Study of an Evening Dose of Eszopiclone on Next Day Driving Ability & Psychomotor/Memory Function in Healthy Volunteers

NCT00368160 | Completed Phase 1

• 1 other identifier: 190-059
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Male and female healthy volunteers. Patients must also possess a full current driving license (for at least one year), and be a regular car driver.

Conditions

Insomnia

Keywords

Next day driving

Outcome Measures

Primary Outcomes (1)

• next day performance in a standardised test of car driving

  9.5 hours post dose

Secondary Outcomes (7)

• Compensatory Tracking Task (CTT)

  9.5 hours post dose

• Rapid Visual Information Processing (RVIP)

  9.5 hours post dose

• Sternberg's Short-term Memory Scanning task (STM)

  9.5 hours post dose

• Critical Flicker Fusion (CFF)

  9.5 hours post dose

• Digit Symbol Substitution Test (DSST)

  9.5 hours post dose

Study Arms (2)

1

EXPERIMENTAL

eszopiclone 3 mg

Drug: Eszopiclone

2

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo

Interventions

Eszopiclone DRUG

eszopiclone 3 mg

Also known as: S-Zopiclone, Lunesta

1

Placebo DRUG

Placebo tablet

2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• Clinically significant use of psychotropic medication in the last three months. For example, this would include the prolonged use of antidepressants, antipsychotics, or antihistamines, but would exclude the occasional use of cold or flu remedies (which often contain antihistamines and/ or opiates)
• The use of any other medication in the last two weeks with the exception of oral, transdermal, IUDs (progestogen only contraceptive e.g. Mirena), or depot contraceptives, non-steroidal analgesics (e.g. ibuprofen), and paracetamol
• 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 (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
• Volunteers 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

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (1)

HPRU Medical Research Centre

Guildford, Surrey, United Kingdom

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2006
• First Posted: August 24, 2006
• Study Start: March 1, 2004
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

GB (1)