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A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia

NCT00386334 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2016-03-14

Study results available
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Summary

To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at bedtime for 12 weeks in elderly subjects with a diagnosis of primary chronic insomnia will be safe and well tolerated, improve subjective sleep measures, improve measures of Quality of Life and next day insomnia symptoms, and have no significant withdrawal central nervous system adverse events or rebound insomnia.

Conditions

Interventions

DRUG

Eszopiclone

2 mg tablet once per day in the evening

DRUG

Placebo

Tablet one per day in the evening.

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director, CNS · Sumitomo Pharma America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00386334 on ClinicalTrials.gov