Duloxetine Versus Placebo in Chronic Low Back Pain

Phase 3 Completed 404 enrolled Eli Lilly and Company

RandomizedSingle-groupQuadruple-blindTreatment

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.

Timeline

Start: 2006-12
Primary completion: 2007-11
Completion: 2007-11

Outcome

Mixed primary results

registry LEAST_SQUARES_MEAN Duloxetine 60 mg: -1.58 (Standard Error 0.18) units on a scale NCT00408876 ↗

registry LEAST_SQUARES_MEAN Placebo: -1.01 (Standard Error 0.18) units on a scale NCT00408876 ↗

registry analysis (superiority or other test); Duloxetine 60 mg vs Placebo; p = 0.026; Repeated Measures NCT00408876 ↗

registry analysis (superiority or other test); Duloxetine 20 mg vs Placebo; p = 0.503; Repeated Measures NCT00408876 ↗

Publications

Williamson OD, Schroer M, Ruff DD, Ahl J, Margherita A, Sagman D, Wohlreich MM. Onset of response with duloxetine treatment in patients with osteoarthritis knee pain and chronic low back pain: a post hoc analysis of placebo-controlled trials. Clin Ther. 2014 Apr 1;36(4):544-51. doi: 10.1016/j.clinthera.2014.02.009. Epub 2014 Mar 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Duloxetine	Small molecule	20 mg	Oral
Subject	Duloxetine	Small molecule	60 mg	Oral
Subject	Duloxetine	Small molecule	120 mg	Oral

Indications

No indication recorded.