Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients

NCT ID: NCT02455271

Last Updated: 2018-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

438 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-01

Study Completion Date

2015-12-22

Brief Summary

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To investigate the safety and efficacy of administration of eszopiclone for 6 months in insomnia participants.

Detailed Description

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Conditions

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Insomnia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with insomnia

Participants with insomnia who will receive eszopiclone per approved label.

Eszopiclone

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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EZOP; Lunesta

Eligibility Criteria

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Inclusion Criteria

1\. Participants who have completed LUN01S and need to continue eszopiclone
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Akira Endo

Role: STUDY_DIRECTOR

Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.

Locations

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Osaka, , Japan

Site Status

Tokyo, , Japan

Site Status

Countries

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Japan

References

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Japanese Journal of Sleep Medicine 11: 81-94, 2017.

Reference Type RESULT

Other Identifiers

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LUN02T

Identifier Type: -

Identifier Source: org_study_id

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