Ramelteon 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Accompanied by Difficulty Falling Asleep> − Transitional Survey From the Preceding Drug-use Survey −

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 −

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02153086
• Other study ID #: 293-011
• Status: Completed
• Phase: N/A
• First received: May 29, 2014
• Last updated: August 1, 2014
• Start date: March 2011
• Est. completion date: June 2014

Study information

• 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

Clinical Trial Summary

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.

Description:

This survey was designed 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.

The usual dosage for adults is 8 mg of ramelteon administered orally once daily at bedtime.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Insomnia

Intervention

Drug:
• Ramelteon
Ramelteon tablets 8 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

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