drugset / Trial / NCT01089556

A Study in Painful Diabetic Neuropathy

NCT01089556

Phase 3 Completed 811 enrolled Eli Lilly and Company Boehringer Ingelheim · collab
RandomizedParallel-groupQuadruple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Duloxetine Small molecule 60 mg Oral
Subject Duloxetine Small molecule 120 mg Oral
Subject Pregabalin Small molecule 300 mg Oral
Subject Pregabalin Small molecule 600 mg Oral

Indications