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Clinical Trials/JPRN-UMIN000013271
JPRN-UMIN000013271
Active, Not Recruiting
N/A

An exploratory observational study to investigate patient background factors of Ramelteon responders

Takeda Pharmaceutical Company Limited0 sites2,200 target enrollmentMarch 1, 2014

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.

Registry
who.int
Start Date
March 1, 2014
End Date
TBD
Last Updated
2 years ago
Study Type
Observational
Sex
All

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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