A Study of Duloxetine (LY248686) in Participants With Diabetic Peripheral Neuropathic Pain (DPNP)

Summary

The main purpose of this study is to evaluate the effectiveness and safety of the study drug known as duloxetine in participants with diabetic peripheral neuropathic pain.

Timeline

Start

2015-04

Primary completion

2017-05-13

Completion

2017-05-13

Outcome

Met primary endpoint

paper the upper bound of the 95% CI (0.439) did not exceed the predefined noninferiority margin (0.51) PMID 30271191 ↗

paper This study demonstrated the noninferior efficacy of duloxetine compared with pregabalin PMID 30271191 ↗

Publications

• Enomoto H, Yasuda H, Nishiyori A, Fujikoshi S, Furukawa M, Ishida M, Takahashi M, Tsuji T, Yoshikawa A, Alev L. Duloxetine in patients with diabetic peripheral neuropathic pain in Japan: a randomized, doubleblind, noninferiority comparative study with pregabalin. J Pain Res. 2018 Sep 13;11:1857-1868. doi: 10.2147/JPR.S170646. eCollection 2018.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Duloxetine	Small molecule	40 mg	Oral
Subject	Duloxetine	Small molecule	60 mg	Oral
Comparator	Pregabalin	Small molecule	300 mg	Oral
Comparator	Pregabalin	Small molecule	600 mg	Oral

Indications