Insomnia
Conditions
Interventions
investigational material(s)
Generic name etc : Rozerem Tablets 8mg (ramelteon)
INN of investigational material :
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage a
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Sleep-onset difficulty associated with insomnia
Exclusion criteria
Exclusion criteria: 1. Patients with previous history of hypersensitivity to an ingredient of Rozerem Tablets 2. Patients with severe liver dysfunction 3. Patients taking fluvoxamine maleate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse drug reactions Primary timeframe: From baseline to 4 weeks of treatment The frequency of adverse drug reactions by type, seriousness, time to onset. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with the study drug are defined as adverse drug reactions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep status (sleep onset latency, total sleep time, number of awakenings) and the patient's score on the Global Impression (PGI) scale Secondary timeframe: From baseline to 4 weeks of treatment 1. The change in sleep status (sleep onset latency, total sleep time, number of awakenings) from the start of the investigation will be summarized and assessed. 2. The results of the survey using the PGI questionnaire will be scored, and 7 items (sleep onset, sleep time, sleep quality, morning awakening, morning tiredness, daytime somnolence, and daytime physical condition/function) will be summarized and assessed. | — |
Outcome results
None listed