At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 401 enrolled
Drug / intervention
Duloxetine +1 moredrug
Likely dose
Duloxetine 60 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.
Effect of Duloxetine 60 mg Once Daily Versus Placebo in Patients With Chronic Low Back Pain
In Brief
A Phase 3 clinical trial evaluating Duloxetine and Placebo for Chronic Low Back Pain. Completed, enrolled 401 participants across 26 sites in 7 countries.
Detailed Summary
The purpose of this study is to determine if duloxetine reduces the severity of chronic low back pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Low Back Pain
CountriesBrazil, Germany, Netherlands, Poland, Russia, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2008
First PostedOct 2008
Primary CompletionJul 2009
TodayJul 2026
First PostedOct 7, 2008
Enrollment StartSep 1, 2008
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.7 years ago
Interventions
Duloxetinedrug
60 mg orally once daily for 12 weeks
Placebodrug
Placebo once daily orally for 12 weeks