NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-142504

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedInsomnia
Date of first enrollment11/3/2011
Target sample size100
Countries of recruitment
Study typeOBSERVATIONAL
Intervention(s)Intervention name : Rozerem 8 mg Tablets (ramelteon) Dosage And administration of the intervention : The usual dosage for adults is 8 mg of ramelteon administered orally once daily at bedtime. Control intervention name : null

Outcome(s)

Primary OutcomeFrequency of adverse drug reactions Primary timeframe For 6 months (for 1 year in patients for whom follow-up can be performed) 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.
Secondary OutcomeChanges from baseline in sleep status (sleep latency, total sleep time, and number of awakenings) and patient global impression (PGI) score Secondary timeframe From baseline to 6 months of treatment (For 1 year in patients for whom follow-up can be performed) (1) Changes from baseline in sleep status (sleep latency, total sleep time, and number of awakenings) from the start of the surveillance will be tabulated and assessed. (2) 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.

Key inclusion & exclusion criteria

Age minimum
Age maximum
GenderBOTH
Include criteriaPatients 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
Exclude criteriaPatients 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

Related Information

Contact

public contact
Name Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information
Address https://www.takeda.co.jp/contact/form/jp/form/
Telephone
E-mail
Affiliation
scientific contact
Name Takeda Pharmaceutical Company Limited Post Marketing Surveillance, Pharm(continued to "Affiliation")
Address https://www.takeda.co.jp/contact/form/jp/form/
Telephone
E-mail
Affiliation acovigilance Department, Takeda Development Center Japan