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

Hallux Valgus Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Tapentadol Immediate-Release Formulation in the Treatment of Acute Pain From Bunionectomy; Bridging Study for Korea

Clinical Trial 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.

Clinical Trial Description

This is a randomized (study drug assigned by chance like flipping a coin), double-blind (neither physician nor patient knows the name of the assigned drug), placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of tapentadol immediate-release (IR) 50 mg and 75 mg in patients who are undergoing bunionectomy (a surgical procedure to remove a bunion). This study was designed to be a similar study to the pivotal global study of PAI-3003/KF32 in order to bridge the results from the global studies and to show similarity in effect of tapentadol between Korean and Caucasian population which will allow extrapolation of the foreign clinical data of tapentadol into Korea. The study will be divided into screening period, surgical period, qualification period, and a double-blind treatment period. The study length, including the screening period, will be up to a maximum duration of 32 days. Eligible patients will be randomly assigned to 1 of 3 treatment groups (tapentadol IR 50 mg, tapentadol IR 75 mg or placebo) in a 1:1:1 ratio. Efficacy and safety assessments will be performed during the study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01516008
Study type Interventional
Source Janssen Research & Development, LLC
Contact
Status Completed
Phase Phase 3
Start date January 2012
Completion date February 2013
View Details
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