drugset / Trial / NCT00635349

A Comparative Study of Tramadol Hydrochloride Plus Acetaminophen Tablets Maintenance Versus Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Maintenance in Participants With Knee Osteoarthritis

NCT00635349

Phase 4 Completed 143 enrolled Janssen Korea, Ltd., Korea
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the effectiveness of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg maintenance with that of non-steroidal anti-inflammatory drugs (NSAIDs) maintenance in participants with knee osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) whose pain was relieved after the add-on treatment of tramadol hydrochloride to NSAIDs.

Timeline

Start
2007-05
Primary completion
2009-04
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Aceclofenac Small molecule 100 mg
Subject Acetaminophen Small molecule 325 mg
Subject Meloxicam Small molecule 7.5 mg
Subject Meloxicam Small molecule 15 mg
Subject Tramadol Other / unclassified 37.5 mg

Indications