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Effects of Ramelteon on Driving Ability

This study has been completed.

Sponsors and Collaborators: Utrecht Institute for Pharmaceutical Sciences
Takeda Europe Research & Development Centre Ltd.
Information provided by: Utrecht Institute for Pharmaceutical Sciences
ClinicalTrials.gov Identifier: NCT00319215
  Purpose

The primary purpose of this study is to investigate the effects of bedtime administration of a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on next-morning on-road driving performance. In addition, the drugs' effects on balance are evaluated during the night, and the next morning residual effects on memory and psychomotor performance.


Condition Intervention Phase
Insomnia
Drug: Ramelteon 8 mg
Drug: Zopiclone 7.5 mg
Phase I

MedlinePlus related topics:   Memory   

Drug Information available for:   Ramelteon    Zopiclone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study
Official Title:   A Study to Investigate the Residual Effects of Ramelteon (8 mg), Zopiclone (7.5 mg) and Placebo on Actual Driving, Memory, Psychomotor Performance and Mood

Further study details as provided by Utrecht Institute for Pharmaceutical Sciences:

Primary Outcome Measures:
  • Standard Deviation of Lateral Position (SDLP); i.e. the weaving of the car.
  • Standard Deviation of Speed (SDS)

Secondary Outcome Measures:
  • Mean Speed (MS)
  • Mean Lateral Position (MLP)
  • Word Learning test:Immediate recall, Delayed Recall, Recognition time & score
  • Sternberg memory scanning test: reaction time and % errors
  • Tracking task: RMS (tracking error)
  • Divided attention test: RMS,reaction time and % errors
  • DSST: number of copied symbols

Estimated Enrollment:   30
Study Start Date:   March 2006
Study Completion Date:   July 2006

  Eligibility
Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  1. The subject is male or female, 21 - 55 years of age, inclusive
  2. The subject is capable of understanding and complying with the protocol requirements.
  3. The subject or the subject’s legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures.
  4. The subject, if female, is non-pregnant and non-lactating.
  5. Possession of a valid driver’s license for at least 3 years and a reported history of having driven at least 5000 km per year on average, for the last 3 years prior to entering into the trial.
  6. An SDLP level at the end of the driving test of the dress rehearsal that does not exceed 24 cm. This dress rehearsal is performed at Visit 1.

Exclusion Criteria:

  1. The subject has a known hypersensitivity to ramelteon, zopiclone or related compounds, including melatonin.
  2. The subject has participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first night of double-blind study medication, whichever is longer.

5.History or presence of any clinically significant gastrointestinal, cardiovascular, hepatic, renal, haematological, endocrine, respiratory, neurological or psychiatric disease 6.History of primary insomnia (DSM IV-TR criteria) within the past 6 months. 7.The subject has used any medication with psychotropic effects (e.g. antidepressants, anxiolytics, antihistamines) within 30 days of the initial visit.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319215

Locations
Netherlands
Utrecht Institute for Pharmaceutical Sciences    
      Utrecht, Netherlands, 3584CA

Sponsors and Collaborators
Utrecht Institute for Pharmaceutical Sciences
Takeda Europe Research & Development Centre Ltd.

Investigators
Principal Investigator:     Joris Verster, PhD     Utrecht Institute for Pharmaceutical Sciences    
  More Information


Study ID Numbers:   05/316, Studynumber:TAK-375/EC103, EudraCT Number 2005-005553-22
First Received:   April 26, 2006
Last Updated:   April 24, 2007
ClinicalTrials.gov Identifier:   NCT00319215
Health Authority:   Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Utrecht Institute for Pharmaceutical Sciences:
ramelteon  
zopiclone  
driving  
memory
balance
psychomotor

Study placed in the following topic categories:
Zopiclone

Additional relevant MeSH terms:
Therapeutic Uses
Physiological Effects of Drugs
Hypnotics and Sedatives
Central Nervous System Depressants
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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