Efficacy and Safety of Gabapentin/B-complex Versus Pregabalin in Diabetic Peripheral Neuropathy Pain Management

Phase 4 Completed 353 enrolled Merck KGaA, Darmstadt, Germany Merck S.A. de C.V., Mexico · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, randomized, open-label, parallel, Phase 4 clinical trial to compare efficacy and safety of gabapentin/B-complex versus pregabalin in diabetic peripheral neuropathy pain (DPNP) management.

Timeline

Start: 2011-04
Primary completion: 2012-07
Completion: 2012-07

Publications

Mimenza Alvarado A, Aguilar Navarro S. Clinical Trial Assessing the Efficacy of Gabapentin Plus B Complex (B1/B12) versus Pregabalin for Treating Painful Diabetic Neuropathy. J Diabetes Res. 2016;2016:4078695. doi: 10.1155/2016/4078695. Epub 2016 Jan 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CYANOCOBALAMIN	Small molecule	20 mg	Oral
Subject	Gabapentin	Small molecule	3600 mg	Oral
Comparator	Pregabalin	Small molecule	600 mg	Oral
Subject	Thiamine	Other / unclassified	100 mg	Oral

Efficacy and Safety of Gabapentin/B-complex Versus Pregabalin in Diabetic Peripheral Neuropathy Pain Management

Summary

Timeline

Publications

Drugs

Indications