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Effects of Ramelteon on Driving Ability
This study has been completed.
Study NCT00319215   Information provided by Utrecht Institute for Pharmaceutical Sciences
First Received: April 26, 2006   Last Updated: April 24, 2007   History of Changes

April 26, 2006
April 24, 2007
March 2006
 
  • Standard Deviation of Lateral Position (SDLP); i.e. the weaving of the car.
  • Standard Deviation of Speed (SDS)
Same as current
Complete list of historical versions of study NCT00319215 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
Effects of Ramelteon on Driving Ability
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

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.

 
Phase I
Interventional
Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study
Insomnia
  • Drug: Ramelteon 8 mg
  • Drug: Zopiclone 7.5 mg
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
30
July 2006
 

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.

Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00319215
 
05/316, Studynumber:TAK-375/EC103, EudraCT Number 2005-005553-22
Utrecht Institute for Pharmaceutical Sciences
Takeda Europe Research & Development Centre Ltd.
Principal Investigator: Joris Verster, PhD Utrecht Institute for Pharmaceutical Sciences
Utrecht Institute for Pharmaceutical Sciences
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP