Insomnia Clinical Trial
Official title:
Rozerem 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Associated With Sleep-onset Difficulty > − Transitional Survey From the Preceding Drug-use Survey −
Verified date | August 2014 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Observational |
The purpose of this survey is to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in patients with difficulty falling asleep associated with insomnia in daily medical practice.
Status | Completed |
Enrollment | 236 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients with difficulty falling asleep associated with insomnia who have completed a 4-week follow-up in the preceding drug use surveillance and are able to receive continuous administration of Rozerem Tablets Exclusion Criteria: - Patients with contraindications to Rozerem Tablets 1. Patients with previous history of hypersensitivity to ingredients in Rozerem Tablets 2. Patients with severe liver dysfunction 3. Patients taking fluvoxamine maleate |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Takeda |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of adverse drug reactions | The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of ramelteon whether or not it was considered related to treatment. Among these, events that are considered as having a causal relationship with ramelteon are defined as adverse drug reactions. | For 6 months (for 1 year in patients for whom follow-up can be performed) | Yes |
Secondary | Sleep status (sleep latency, total sleep time, and number of awakenings) | Changes from baseline in sleep status from the start of the surveillance will be tabulated and assessed. | From baseline to 6 months of treatment (for 1 year in patients for whom follow-up can be performed) | No |
Secondary | Change from baseline in patient global impression (PGI) score | Results of surveys using the PGI questionnaire will be scored, and scores for 7 items (sleep onset, sleep duration, sleep quality, morning awakening, remaining tiredness in the morning, daytime somnolence, and daytime physical condition/function) will be tabulated and assessed. | From baseline to 6 months of treatment (for 1 year in patients for whom follow-up can be performed) | No |
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