A Study in Painful Diabetic Neuropathy

Summary

This study will investigate the efficacy of a combination treatment of duloxetine + pregabalin compared with the maximal dose of each drug in monotherapy, in patients with diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard recommended dose of either drug. It will provide an answer to a common clinical question, namely, is it better to increase the dose of the current monotherapy or to combine both treatments early on, in patients who do not respond to standard doses of duloxetine or pregabalin.

Timeline

Start

2010-03

Primary completion

2011-11

Completion

2011-11

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Combination vs Monotherapy; p = 0.370; LS Mean Differences (Final Values) -0.192; Mixed Models Analysis NCT01089556 ↗

Drugs

Indications