A Study in Participants With Diabetic Peripheral Neuropathic Pain in China

Summary

The purpose of this trial is to assess the efficacy of duloxetine 60 milligrams (mg) once daily (QD) compared with placebo, on the change in pain severity from baseline to 12 weeks as measured by the weekly mean of the daily pain scores recorded in the participant's diary in participants with diabetic peripheral neuropathic pain.

Timeline

Start

2011-04

Primary completion

2013-08

Completion

2013-08

Outcome

Met primary endpoint

registry analysis (superiority or other test); Duloxetine vs Placebo; p = 0.030; Mean Difference (Final Values) -0.43 (95% CI -0.82 to -0.04); Mixed Models Analysis NCT01179672 ↗

Publications

• Gao Y, Guo X, Han P, Li Q, Yang G, Qu S, Yue L, Wang CN, Skljarevski V, Duenas H, Raskin J, Gu L. Treatment of patients with diabetic peripheral neuropathic pain in China: a double-blind randomised trial of duloxetine vs. placebo. Int J Clin Pract. 2015 Sep;69(9):957-66. doi: 10.1111/ijcp.12641. Epub 2015 May 4.

Drugs

Indications