Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy

Phase 3 Completed 450 enrolled Avanir Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.

Timeline

Start: 2005-07
Primary completion: 2007-02
Completion: 2007-02

Outcome

Met primary endpoint

paper On all six scales, DMQ 45/30 mg was significantly superior to placebo, including the primary efficacy analysis PMID 22314263 ↗

Publications

Results Shaibani AI, Pope LE, Thisted R, Hepner A. Efficacy and safety of dextromethorphan/quinidine at two dosage levels for diabetic neuropathic pain: a double-blind, placebo-controlled, multicenter study. Pain Med. 2012 Feb;13(2):243-54. doi: 10.1111/j.1526-4637.2011.01316.x. Epub 2012 Feb 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dextromethorphan	Unknown	30 mg	—
Subject	Dextromethorphan	Unknown	45 mg	—
Subject	Quinidine	Small molecule	30 mg	—