drugset / Trial / NCT01814878

A Study Comparing the Effectiveness and Safety of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen With Immediate Release (IR) Tramadol HCl/Acetaminophen in Participants With Moderate to Severe Postoperative Pain

NCT01814878

Phase 3 Completed 320 enrolled Janssen Korea, Ltd., Korea
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to compare the efficacy and safety of extended release (ER) tramadol hydrochloride (HCl)/acetaminophen with immediate release (IR) tramadol HCl/acetaminophen in participants with moderate to severe (very serious, life threatening) postoperative pain.

Timeline

Start
2009-11
Primary completion
2011-01
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tramadol Other / unclassified 37.5 mg
Comparator Tramadol Other / unclassified 75 mg
Comparator Tramadol Other / unclassified 325 mg
Comparator Tramadol Other / unclassified 650 mg

Indications