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.
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
- 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