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

NCT00368056 | Completed Phase 3

• 1 other identifier: 190-060
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Insomnia

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: No
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (1)

HPRU Medical Research Centre, University of Surrey

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 3
• 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: April 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

GB (1)