At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 36 enrolled
Drug / intervention
Eszopiclone +1 moredrug
Likely dose
Eszopiclone 3mgfrom 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 in the Treatment of Insomnia and Associated Symptoms of Fibromyalgia
In Brief
A Phase 4 clinical trial evaluating Eszopiclone and placebo for Fibromyalgia and Insomnia. Completed, enrolled 36 participants across 1 site.
Detailed Summary
The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other symptoms of fibromyalgia. It is hypothesized that participants receiving eszopiclone will report greater improvement in total sleep time, sleep quality, pain, fatigue, physical functioning, and emotional distress than will those receiving placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia, Insomnia
CountriesUnited States
CollaboratorsSumitomo Pharma America, Inc.
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2006
First PostedOct 2006
Primary CompletionMar 2009
TodayJul 2026
First PostedOct 25, 2006
Enrollment StartAug 1, 2006
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 19.7 years ago
Interventions
Eszopiclonedrug
3mg qpm for 12 weeks
placebodrug
1 pill qpm for 12 weeks