Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Rozerem Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty|
- Number of Participants Reporting One or More Adverse Drug Reactions [ Time Frame: Baseline up to 6 weeks ]Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE 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.
- Number of Participants Reporting One or More Serious Adverse Drug Reactions [ Time Frame: Baseline up to 6 weeks ]Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- Sleep Status: Sleep Onset Latency [ Time Frame: Baseline and Week 4 ]Sleep status was determined by measuring the sleep onset latency, defined as the length of time taken from lying down for the night until sleep onset.
- Sleep Status: Total Sleep Time [ Time Frame: Baseline and Week 4 ]Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode.
- Sleep Status: Number of Awakenings [ Time Frame: Baseline and Week 4 ]Sleep status of participants was assessed and summarized by calculating the number of times participants had awaken from the time of start of the investigation.
- Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4 [ Time Frame: Week 4 ]PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. 7 items on scale include sleep onset, sleep time, sleep quality, morning awakening, morning tiredness, daytime somnolence, and daytime physical condition/function. Participants provide their response on a PGI questionnaire. The results of survey using the PGI questionnaire was scored, summarized and assessed. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported for sleep onset,time, quality; morning awakening, tiredness and daytime sleepiness, physical condition.
|Study Start Date:||July 2010|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
|Ramelteon 8 mg administered orally once daily||
Ramelteon 8 mg tablets
Other Name: Rozerem
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02058992
|Study Chair:||Postmarketing Group Manager||Takeda|