Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)

Phase 3 Completed 217 enrolled Viatris Inc.

RandomizedCrossoverDouble-blindTreatment

Summary

The intent of this study is to treat subjects with painful Diabetic Peripheral Neuropathy (DPN) who also have pain on walking and to determine whether or not pregabalin demonstrates improvement relative to placebo on the following: reducing DPN pain, reducing pain on walking, and providing other benefits associated with daily activities and quality of life.

Timeline

Start: 2011-10
Primary completion: 2013-07
Completion: 2013-07

Outcome

Missed primary endpoint

registry analysis (unspecified test); Pregabalin vs Placebo; p = 0.0659; Mean Difference (Final Values) -0.22 (95% CI -0.46 to 0.01) NCT01474772 ↗

registry analysis (unspecified test); Pregabalin vs Placebo; p = 0.4120; Mean Difference (Final Values) -0.13 (95% CI -0.44 to 0.18) NCT01474772 ↗

paper no statistically significant treatment difference for pregabalin versus placebo in the co-primary efficacy endpoints PMID 25565583 ↗

Publications

Huffman C, Stacey BR, Tuchman M, Burbridge C, Li C, Parsons B, Pauer L, Scavone JM, Behar R, Yurkewicz L. Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain on Walking. Clin J Pain. 2015 Nov;31(11):946-58. doi: 10.1097/AJP.0000000000000198.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	150 mg	—
Subject	Pregabalin	Small molecule	300 mg	—