At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 12 enrolled
Drug / intervention
eszopiclonedrug
Likely dose
Not stated in 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.
Eszopiclone Treatment & Cortisol Response to HPA Axis Tests
In Brief
A Phase 4 clinical trial evaluating eszopiclone for Insomnia. Completed, enrolled 12 participants across 1 site.
Detailed Summary
This study was designed to use a sensitive neuroendocrine probe, the Dexamethasone/Corticotropin-Releasing Hormone (DEX/CRH) test, in a sample of healthy adults with insomnia. The primary aim was to assess cortisol reactivity before and after long-term (6 weeks) administration of eszopiclone. It was hypothesized that treatment with eszopiclone would result in a significant reduction in plasma cortisol response to the DEX/CRH test following treatment of insomnia with standard dose of eszopiclone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesUnited States
CollaboratorsSumitomo Pharma America, Inc.
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
Primary CompletionDec 2008
First PostedApr 2009
Study CompletionAug 2009
TodayJul 2026
First PostedApr 28, 2009
Enrollment StartMay 1, 2007
Primary CompletionDec 1, 2008
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.2 years ago
Interventions
eszopiclonedrug
6 weeks standard oral therapy