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 -
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 236
- 主要终点
- Number of Participants Reporting One or More Adverse Drug Reactions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ramelteon 8 mg Tablets
干预措施: Ramelteon (Drug)
结局指标
主要结局
Number of Participants Reporting One or More Adverse Drug Reactions
时间窗: 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.
次要结局
- Sleep Status: Number of Awakenings(Baseline, Week 4 and 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))
- Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Duration(At Week 4, 52, and final assessment (up to 12 months))
- Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Somnolence(At Week 4, 52, and final assessment (up to 12 months))
- Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Quality(At Week 4, 52, and final assessment (up to 12 months))
- Percentage of Participants Reported With Improvement on the PGI Scale for Morning Awakening(At Week 4, 52, and final assessment (up to 12 months))
- 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))
- 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))
- Sleep Status: Sleep Onset Latency(Baseline, Week 4 and Month 12)
- Sleep Status: Total Sleep Time(Baseline, Week 4 and Month 12)