JPRN-UMIN000013271
Active, Not Recruiting
N/A
An exploratory observational study to investigate patient background factors of Ramelteon responders
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Takeda Pharmaceutical Company Limited
- Enrollment
- 2200
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.A patient with a diagnosis of insomnia with difficulty falling asleep who has been started on treatment with oral Ramelteon 8 mg/day
- •2\.A patient who has answered the Insomnia Severity Index (ISI) questionnaire and the health\-related QOL scale Short Form\-8 (SF\-8\) in routine clinical settings before the start of Ramelteon therapy
- •3\.A patient who has given consent to the use of clinical information for the study at 20 years of age or older
Exclusion Criteria
- •1\.A patient who has received Ramelteon within 4 weeks before the start of oral ramelteon therapy
- •2\.A patient with dementia
- •3\.A patient with a history of hypersensitivity to Ramelteon
- •4\.A patient with severe hepatic impairment
- •5\.A patient with a history of drug abuse
- •6\.A patient with psychiatric disease in an unstable condition
- •7\.A patient who, in the opinion of the principal investigator or co\-investigator, is not appropriate for the study
Outcomes
Primary Outcomes
Not specified
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