Maintenance of Effect of Duloxetine in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

Summary

To determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from Diabetic Neuropathy.

Timeline

Start

2006-04

Primary completion

2007-10

Completion

2007-10

Outcome

Met primary endpoint

paper 0.79 as the upper bound of the one-sided 97.5% CI, which was less than the pre-specified non-inferiority margin of 1.5 (p < 0.001). PMID 19637208 ↗

Publications

• Results Skljarevski V, Desaiah D, Zhang Q, Chappell AS, Detke MJ, Gross JL, Ziegler D. Evaluating the maintenance of effect of duloxetine in patients with diabetic peripheral neuropathic pain. Diabetes Metab Res Rev. 2009 Oct;25(7):623-31. doi: 10.1002/dmrr.1000.
• Hall JA, Wang F, Oakes TM, Utterback BG, Crucitti A, Acharya N. Safety and tolerability of duloxetine in the acute management of diabetic peripheral neuropathic pain: analysis of pooled data from three placebo-controlled clinical trials. Expert Opin Drug Saf. 2010 Jul;9(4):525-37. doi: 10.1517/14740338.2010.484418.

Drugs

Indications