At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 58 enrolled
Drug / intervention
Eszopiclone +1 moredrug
Likely dose
Eszopiclone 3 mg orally nightlyAI-extracted
Key inclusion· 9
- ✓Diagnosis of insomnia due to chronic low back pain per DSM-IV criteria
- ✓Insomnia onset within 1 month of back pain onset
- ✓Total Sleep Time <6.5 hours and/or Sleep Onset Latency >30 minutes in past month
- ✓Insomnia Severity Index >14 (at least moderate insomnia)
Key exclusion· 13
- ✕Significant medical or neurological illness beyond that directly responsible for chronic low back pain
- ✕Active and significant psychiatric disease with substantive impact on sleep
- ✕DSM-IV Axis I disorder within last 3 months or substance abuse within last 12 months
- ✕Creatinine ≥2.0 or abnormal kidney function at screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Double-blind, Placebo-controlled Study of the Safety and Efficacy of Eszopiclone in the Treatment of Insomnia in Patients With Chronic Low Back Pain
In Brief
A Phase 4 clinical trial evaluating Eszopiclone and Placebo for Primary Insomnia. Completed, enrolled 58 participants across 1 site.
Detailed Summary
The purpose of this study is to examine whether insomnia due to chronic low back pain can improve with use of eszopiclone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Insomnia
CountriesUnited States
CollaboratorsSumitomo Pharma America, Inc.
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2006
First PostedAug 2006
Primary CompletionSep 2010
TodayJul 2026
First PostedAug 18, 2006
Enrollment StartAug 1, 2006
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 19.9 years ago
Interventions
Eszopiclonedrug
Eszopiclone 3 mg po nightly for duration of study blind phase.
Placebodrug
Placebo nightly over duration of double blind study phase