At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients With Chronic Low Back Pain
In Brief
A Phase 3 clinical trial evaluating Duloxetine and Placebo for Back Pain Without Radiation. Completed, enrolled 236 participants across 17 sites in 5 countries.
Detailed Summary
The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition. Whether duloxetine once daily can help patients with Chronic Low Back Pain. Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.
Study Details
Timeline
Interventions
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
every day (QD), by mouth (PO), 13 weeks