Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty

Insomnia Clinical Trial

Official title:

Rozerem Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02058992
• Other study ID #: 293-101
• Secondary ID: JapicCTI-132358
• Status: Completed
• Phase: N/A
• First received: February 7, 2014
• Last updated: February 7, 2014
• Start date: July 2010
• Est. completion date: April 2013

Study information

• Verified date: February 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 study is to investigate the safety and efficacy of ramelteon (Rozerem) when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia.

Description:

This is a drug use surveillance planned to examine the safety and efficacy of ramelteon tablets when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia (planned sample size, 3000)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3339
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Sleep-onset difficulty associated with insomnia

Exclusion Criteria:

1. Patients with previous history of hypersensitivity to an ingredient of 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 8 mg tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse drug reactions	The frequency of adverse drug reactions by type, seriousness, time to onset. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with the study drug are defined as adverse drug reactions.	From baseline to Week 4	Yes
Secondary	Sleep status (sleep onset latency, total sleep time, number of awakenings)	The change in sleep status (sleep onset latency, total sleep time, number of awakenings) from the start of the investigation will be summarized and assessed.	From baseline to 4 weeks of treatment	No
Secondary	The patient's score on the Global Impression (PGI) scale	The results of the survey using the PGI questionnaire will be scored, and 7 items (sleep onset, sleep time, sleep quality, morning awakening, morning tiredness, daytime somnolence, and daytime physical condition/function) will be summarized and assessed.	From baseline to 4 weeks of treatment	No