drugset / Trial / NCT01516008

A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy

NCT01516008

Phase 3 Completed 353 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to demonstrate the efficacy of at least 1 dose of tapentadol IR 50 mg and/or 75 mg versus placebo using the sum of pain intensity difference at 48 hours (SPID48) to measure analgesic effect in Korean patients with acute pain following bunionectomy.

Timeline

Start
2012-01
Primary completion
2013-02
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Tapentadol Small molecule 50 mg Oral
Subject Tapentadol Small molecule 75 mg Oral

Indications