Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients
Sponsor
Eisai Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02452684
Collaborator
(none)
4,876
2
38.7
2438
63
Study Details
Study Description
Brief Summary
To investigate the safety and efficacy of administration of eszopiclone for 4 weeks in insomnia patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
4876 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients (Study LUN01S)
Actual Study Start Date
:
Oct 1, 2012
Actual Primary Completion Date
:
Nov 11, 2014
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 [Up to 4 weeks]
Participants will be interviewed regarding sleep improvement at 4 weeks after first dose or discontinuation relative to predose, and select the appropriate answer of: 1. Improved 2. Unchanged 3. Worse 4. Indiscernible
Secondary Outcome Measures
- Number of participants with adverse events (AEs) [Up to 4 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Insomnia participants who did not take eszopiclone before assessment
-
Participants who receive assessment by using sleep questionaries
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:
NCT02452684
Other Study ID Numbers:
- LUN01S
First Posted:
May 25, 2015
Last Update Posted:
Sep 7, 2018
Last Verified:
Jan 1, 2017
Keywords provided by Eisai Co., Ltd.
Additional relevant MeSH terms: