A Phase 1 interventional study of Eszopiclone and Placebo in Insomnia, sponsored by Sumitomo Pharma America, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-22.
Sponsored by Sumitomo Pharma America, Inc. · Phase 1, Interventional, and Treatment
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.
The study is a single centre, randomised, double blind, placebo controlled 2-way crossover design in a group of 32 healthy male and female volunteers. The medications under investigation are eszopiclone and placebo. Volunteers 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.
Sumitomo Pharma America, Inc. is the lead sponsor of 176 studies on the registry; 5 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 20 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
eszopiclone 3 mg
Drug: Eszopiclone
Placebo tablet
Drug: Placebo
eszopiclone 3 mg
Also known as: S-Zopiclone, Lunesta
Placebo tablet
next day performance in a standardised test of car driving
Time frame: 9.5 hours post dose
Compensatory Tracking Task (CTT)
Time frame: 9.5 hours post dose
Rapid Visual Information Processing (RVIP)
Time frame: 9.5 hours post dose
Sternberg's Short-term Memory Scanning task (STM)
Time frame: 9.5 hours post dose
Critical Flicker Fusion (CFF)
Time frame: 9.5 hours post dose
Digit Symbol Substitution Test (DSST)
Time frame: 9.5 hours post dose
Choice Reaction Time (CRT)
Time frame: 9.5 hours post dose
Leeds Sleep Evaluation Questionnaire and Leeds Analogue Rating Scales
Time frame: 9.5 hours post dose
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Sumitomo Pharma America, Inc.