A Study of Ramelteon in Chinese Patients With Chronic Insomnia
ConditionChronic Insomnia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanjing Chia-tai Tianqing Pharmaceutical
About this trial
The purpose of this study is to assess the efficacy and safety of Ramelteon in chinese patients with chronic insomnia.
Efficacy will be evaluated on objective and subjective sleep parameters.
Eligibility criteria
Qualifiers
Male or female aged ≥ 18 years old.
Chronic insomnia disorder diagnosed according to International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) criteria.
Self-reported history of all the following on at least 3 nights per week within 4 weeks prior to screening: subjective sleep latency (sSL) greater than or equal to 30 minutes, and subjective total sleep time (sTST) less than or equal to 6.5 hours per night.
Meeting all the following sleep parameters on the 2 PSG nights during the run-in period: mean latency to persistent sleep (LPS) ≥ 20 min (with neither of the two nights < 15 min), and mean wake after sleep onset (WASO) ≥ 30 min (with neither of the two nights < 20 min).
Disqualifiers
Use of ramelteon within 30 days prior to screening.
Previous non-responders to melatonin receptor agonist therapy.
Known hypersensitivity to ramelteon or related compounds, including melatonin.
Sleep schedule changes required by employment (e.g. shift worker), or has flown across greater than three time zones (mainland China is considered as 1 time zone) within 30 days prior to screening and during the study period; or special professionals who need to operate machinery during the study period, such as professional drivers, high-altitude operators, etc.
Trial design
Treatments tested in this trial
- Ramelteon
- Ramelteon placebo
Treatment groups
280 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov