CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 388 enrolled
Drug / intervention
Eszopiclone +1 moredrug
Likely dose
Eszopiclone 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00386334
NCT00386334Phase 4Completed
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A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly Subjects With Primary Chronic Insomnia

Sumitomo Pharma America, Inc.·interventional·Posted Oct 11, 2006·Updated Mar 14, 2016

In Brief

A Phase 4 clinical trial evaluating Eszopiclone and Placebo for Insomnia. Completed, enrolled 388 participants across 82 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 11, 2006
Enrollment StartOct 1, 2006
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.7 years ago

Interventions

Eszopiclonedrug

2 mg tablet once per day in the evening

Placebodrug

Tablet one per day in the evening.