A Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain

Summary

The purpose of the study is to assess the efficacy and safety of duloxetine in participants with Chronic Low Back Pain (CLBP).

Timeline

Start

2013-05

Primary completion

2014-07

Completion

2014-07

Outcome

Met primary endpoint

registry analysis (superiority or other test); Duloxetine vs Placebo; p = 0.0026; Mean Difference (Final Values) -0.46 (95% CI -0.77 to -0.16) NCT01855919 ↗

Publications

• Enomoto H, Sasaki N, Fujikoshi S, Yoshikawa A, Tsuji T, Takeshita K. Relationship Between Pain Alleviation and Disease-specific Health-related Quality of Life Measures in Patients With Chronic Low Back Pain Receiving Duloxetine: Exploratory Post Hoc Analysis of a Japanese Phase 3 Randomized Study. J Am Acad Orthop Surg Glob Res Rev. 2019 Nov 27;3(11):e18.00086. doi: 10.5435/JAAOSGlobal-D-18-00086. eCollection 2019 Nov.
• Tsuji T, Itoh N, Ishida M, Ochiai T, Konno S. Response to duloxetine in chronic low back pain: exploratory post hoc analysis of a Japanese Phase III randomized study. J Pain Res. 2017 Sep 4;10:2157-2168. doi: 10.2147/JPR.S138172. eCollection 2017.

Drugs

Indications

No indication recorded.