A Randomized Double-Blind Study Testing the Effects of Pregabalin on Diabetic Neuropathy

Phase 4 Completed 40 enrolled Duke University Pfizer · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is designed to examine how pregabalin affects parameters of autonomic nerve regulation in correlation with change in pain, anxiety, and depressive symptoms in patients with diabetic neuropathy.

Timeline

Start: 2006-03
Primary completion: 2008-05
Completion: 2008-05

Outcome

Met primary endpoint

paper Compared with placebo, pregabalin treatment resulted in significant improvement in HRV measured by frequency domain analysis PMID 21346609 ↗

paper reduction in low frequency-high frequency ratio (-1.30 ± 2.89 vs 0.37 ± 0.33, P = 0.03) PMID 21346609 ↗

Publications

Results Jiang W, Ladd S, Martsberger C, Feinglos M, Spratt SE, Kuchibhatla M, Green J, Krishnan R. Effects of pregabalin on heart rate variability in patients with painful diabetic neuropathy. J Clin Psychopharmacol. 2011 Apr;31(2):207-13. doi: 10.1097/JCP.0b013e31820f4f57.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	75 mg	—
Subject	Pregabalin	Small molecule	300 mg	—