A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
- Conditions
- Insomnia
- Interventions
- Registration Number
- NCT00770692
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.
- Detailed Description
This is a multicenter, randomized, double-blinded study to evaluate the long-term safety of SEP-190 (2, 3 mg) in non-elderly patients with insomnia and SEP-190 (1, 2 mg) in elderly patients with insomnia.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 369
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Eszopiclone 2 mg- Elderly Eszopiclone 2 mg- Elderly - Eszopiclone 3 mg- Non-elderly Eszopiclone 3 mg- Non-elderly - Eszopiclone 1 mg- Elderly Eszopiclone 1 mg- Elderly - Eszopiclone 2 mg- Non-elderly Eszopiclone 2 mg- Non-elderly -
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events Up to 25 weeks (24 weeks treatment period & 1 week follow-up) Incidence of adverse events was defined as: (number of participants with adverse events/ number of participants analyzed in the safety analysis set)\*100.
An adverse event was defined as any unwanted or untoward disease or its symptom, sign, or abnormality in laboratory parameters in a subject who receives a study drug. An adverse event does not necessarily have a causal relationship with the study drug. The investigator or subinvestigator evaluated adverse events and recorded the results in the case report form (CRF). The investigator or subinvestigator recorded all adverse events occurring after the start of study treatment in the CRF, irrespective of the causal relationship with the study drug or the study procedures. All data collected from the follow-up was recorded in CRF.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline In Sleep Latency Baseline (screening period) and 4 weeks of treatment Based on subjective symptoms, the participants recorded their sleep latency (the amount of time measured in minutes it takes to fall asleep) in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the sleep latency of the overall period assessment - sleep latency at baseline (screening period).
Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Baseline (screening period) and 4 weeks of treatment Based on subjective symptoms, the participants recorded their WASO defined as total awakening time from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the WASO of the overall period assessment - WASO at baseline (screening period).
Mean Change From Baseline in Total Sleep Time Baseline (screening period) and 4 weeks of treatment Based on subjective symptoms, the participants recorded their total sleep time defined as total sleeping time from bedtime to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total sleep time of the overall period assessment - total sleep time at baseline (screening period).
Mean Change From Baseline in Total Number of Awakenings Baseline (screening period) and 4 weeks of treatment Based on subjective symptoms, the participants recorded their number of awakenings defined as total number of spontaneous awakenings from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total number of awakenings of the overall period assessment - total number of awakenings at baseline (screening period).