Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients

Insomnia Clinical Trial

Official title:

Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients (Study LUN01S)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02452684
• Other study ID #: LUN01S
• Status: Completed
• Start date: October 1, 2012
• Est. completion date: December 22, 2015

Study information

• Verified date: January 2017
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investigate the safety and efficacy of administration of eszopiclone for 4 weeks in insomnia patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4876
• Est. completion date: December 22, 2015
• Est. primary completion date: November 11, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Insomnia participants who did not take eszopiclone before assessment

2. Participants who receive assessment by using sleep questionaries

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Japanese Journal of Sleep Medicine 10 : 425-441, 2016.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of overall improvement	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	Up to 4 weeks
Secondary	Number of participants with adverse events (AEs)		Up to 4 weeks