drugset / Trial / NCT01047488

Imipramine and Pregabalin Combination in Painful Polyneuropathy

NCT01047488

RandomizedCrossoverQuadruple-blindTreatment

Summary

Polyneuropathy of different etiologies is often associated with pain and the standard treatment for this type of pain is gabapentinoids or antidepressants. The hypothesis of this study is that the combination of the gabapentinoid pregabalin and the antidepressant imipramine will provide better pain relief than the single compounds alone. This is a randomized, placebo-controlled, double-blind, 4-way, cross-over trial of pregabalin 300 mg/day, imipramine 75 mg/day and their combination versus placebo. The study will include 60 patients and the treatment outcome will be pain intensity as measured by numeric rating scales.

Timeline

Start
2010-02
Primary completion
2013-03
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Imipramine Small molecule 25 mg
Comparator Imipramine Small molecule 75 mg
Comparator Pregabalin Small molecule 150 mg

Indications