Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients
Sponsor
Eisai Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02455271
Collaborator
(none)
438
2
38.7
219
5.7
Study Details
Study Description
Brief Summary
To investigate the safety and efficacy of administration of eszopiclone for 6 months in insomnia participants.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
438 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients (Study LUN02T)
Actual Study Start Date
:
Oct 1, 2012
Actual Primary Completion Date
:
Mar 30, 2015
Actual Study Completion Date
:
Dec 22, 2015
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Participants with insomnia Participants with insomnia who will receive eszopiclone per approved label. |
Drug: Eszopiclone
The usual dosage of eszopiclone is 2 mg per dose for adults and 1 mg per dose for elderly participants, taken orally before bedtime. The dosage may be adjusted according to the participant's symptoms, but a single dose should not exceed 3 mg in adults and 2 mg in elderly participants.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Assessment of overall improvement [At month 3]
Participants will be interviewed regarding sleep improvement at 3 months after first dose or discontinuation, relative to predose, and select the appropriate answer of: 1. Improved 2. Unchanged 3. Worse 4. Indiscernible
- Assessment of overall improvement [At month 6]
Participants will be interviewed regarding sleep improvement at 6 months after first dose or discontinuation, relative to predose, and select the appropriate answer: 1. Improved 2. Unchanged 3. Worse 4. Indiscernible
Secondary Outcome Measures
- Number of participants with adverse events (AEs) [Up to 6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Participants who have completed LUN01S and need to continue eszopiclone
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Osaka | Japan | |||
2 | Tokyo | Japan |
Sponsors and Collaborators
- Eisai Co., Ltd.
Investigators
- Study Director: Akira Endo, Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eisai Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02455271
Other Study ID Numbers:
- LUN02T
First Posted:
May 27, 2015
Last Update Posted:
Sep 7, 2018
Last Verified:
Jan 1, 2017
Keywords provided by Eisai Co., Ltd.
Additional relevant MeSH terms: