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 -
- Registration Number
- NCT02153086
- Lead Sponsor
- Takeda
- Brief 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 participants with difficulty falling asleep associated with insomnia in daily medical practice.
- Detailed Description
This survey was designed to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in participants 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 236
-Participants 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
- Participants with contraindications to Rozerem Tablets.
- Participants with previous history of hypersensitivity to ingredients in Rozerem Tablets.
- Participants with severe liver dysfunction.
- Participants taking fluvoxamine maleate
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ramelteon 8 mg Tablets Ramelteon -
- Primary Outcome Measures
Name Time Method Number of Participants Reporting One or More Adverse Drug Reactions Baseline up to 12 months Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs 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.
- Secondary Outcome Measures
Name Time Method Sleep Status: Number of Awakenings Baseline, Week 4 and Month 12 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. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).
Percentage of Participants Reported With Improvement on the Patient Global Impression (PGI) Scale for Sleep Onset At Week 4, 52, and final assessment (up to 12 months) Sleep onset was defined as the transition from wakefulness into sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. 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. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Duration At Week 4, 52, and final assessment (up to 12 months) Sleep duration was defined as the total amount of sleep obtained. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. 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. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Somnolence At Week 4, 52, and final assessment (up to 12 months) Daytime somnolence was defined as excessive daytime sleepiness (EDS), characterized by general lack of energy, even after adequate or prolonged night time sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. 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. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Percentage of Participants Reported With Improvement on the PGI Scale for Remaining Tiredness in the Morning At Week 4, 52, and final assessment (up to 12 months) Remaining tiredness in the morning was defined as an experience of fatigue after complete or adequate sleep duration. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. 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. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Quality At Week 4, 52, and final assessment (up to 12 months) Sleep quality was defined as participants satisfaction of the sleep experience, integrating aspects of sleep initiation, sleep maintenance, sleep quantity, and refreshment upon awakening. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. 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. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Percentage of Participants Reported With Improvement on the PGI Scale for Morning Awakening At Week 4, 52, and final assessment (up to 12 months) Morning awakening was defined as the return to the awaked state from any non-rapid eye movement (NREM) to rapid eye movement (REM) sleep stages in the morning. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. 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. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Physical Condition/Function At Week 4, 52, and final assessment (up to 12 months) Daytime physical condition/function was defined as general condition of participant throughout the day after adequate or prolonged night time sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. 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. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Sleep Status: Sleep Onset Latency Baseline, Week 4 and Month 12 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. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).
Sleep Status: Total Sleep Time Baseline, Week 4 and Month 12 Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).