CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 192 enrolled
Drug / intervention
Eszopiclone 1 mg +4 moredrug
Likely dose
Eszopiclone 1 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/NCT00770510
NCT00770510Phase 3Completed
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A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia

Eisai Co., Ltd.·interventional·Posted Oct 10, 2008·Updated Feb 4, 2013

In Brief

A Phase 3 clinical trial evaluating Eszopiclone 1 mg, Eszopiclone 2 mg, and 3 other interventions for Primary Insomnia. Completed, enrolled 192 participants across 20 sites.

Detailed Summary

The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in Japanese participants with primary insomnia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Insomnia
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 10, 2008
Enrollment StartSep 1, 2008
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.7 years ago

Interventions

Eszopiclone 1 mgdrug

Eszopiclone 1 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Eszopiclone 2 mgdrug

Eszopiclone 2 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Eszopiclone 3 mgdrug

Eszopiclone 3 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Placebodrug

Placebo tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Zolpidem Tartrate 10 mgdrug

Zolpidem Tartrate 10 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.