A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Ability of Ramelteon 1 mg, 4 mg, and 8 mg to Alleviate the Insomnia Symptoms Associated With Eastward Bound Jet Lag Across 5 Time Zones in Healthy Adult Volunteers.

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Ability of Ramelteon 1 mg, 4 mg, and 8 mg to Alleviate the Insomnia Symptoms Associated With Eastward Bound Jet Lag Across 5 Time Zones in Healthy Adult Volunteers.

Completed
Phase of Trial: Phase IV

Latest Information Update: 09 Jun 2013

At a glance

  • Drugs Ramelteon (Primary)
  • Indications Insomnia; Jet lag
  • Focus Therapeutic Use
  • Sponsors Takeda Global Research and Development Center
  • Most Recent Events

    • 23 Jan 2009 Actual end date changed from Sep 2007 to Aug 2007 as reported by ClinicalTrials.gov.
    • 23 Jan 2009 Primary outcome amended as reported by ClinicalTrials.gov.
    • 12 Jun 2008 Primary endpoint changed from latency to persistent sleep to alleviate the insomnia symptoms associated with rapid, eastward travel across 5 time zones as reported by ClinicalTrials.gov
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