drugset / Trial / NCT00634543

A Study to Compare Safety and Efficacy of Tramadol Hydrochloride/Acetaminophen With Gabapentin in Participants With Diabetic Neuropathy

NCT00634543

Phase 4 Completed 162 enrolled Janssen Korea, Ltd., Korea
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the effectiveness and safety of tramadol hydrochloride (HCl) 37.5 miligram (mg)/acetaminophen 325 mg compared to gabapentin in participants with diabetic neuropathic (nerve disorder caused by diabetes mellitus) pain.

Timeline

Start
2006-12
Primary completion
2008-10
Completion
2008-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 325 mg
Comparator Gabapentin Small molecule 3600 mg
Subject Tramadol Other / unclassified 37.5 mg

Indications