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

Pain, Postoperative Clinical Trial

Official title: A Randomized, Active-Controlled, Parallel Group, Double-Blind Study to Compare the Efficacy and Safety of Tramadol HCl/Acetaminophen ER and IR in Subjects Who Complain of Moderate to Severe Postoperative Pain

Status Completed

Clinical Trial 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.

Clinical Trial Description

This study is a randomized (study drug assigned by chance), multicenter (when more than 1 hospital or medical school team work on a medical research study), active-controlled, parallel group (each group of participants will be treated at the same time), double-blind (neither physician nor participant knows the treatment that the participant receives) study. The duration of the treatment will be 2 days and will be conducted in 4 periods: screening period (from 33 to 2 days before study drug administration to the first surgical incision), surgical period (to 1 day before study drug administration), qualification period (1 day) and double-blind treatment period (1 to 2 days). Participants will be randomly assigned to 2 groups: study drug treatment group (ER) and comparator treatment group (IR). Participants will be administered 2 tablets of ER tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) along with 2 tablets of placebo matching to IR tramadol HCl/acetaminophen in study drug treatment group; and 2 tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) along with 2 tablets of placebo matching to ER tramadol HCl/acetaminophen in comparator treatment group respectively at 0, 12, 24 and 36 hours. Participants will also be administered 2 tablets of placebo matching to IR tramadol HCl/acetaminophen in study drug treatment group; and 2 tablets of IR tramadol HCl/acetaminophen in comparator treatment group respectively at 6, 18, 30 and 42 hours. Participants will be administered investigational product at 6-hour interval from the time of the first investigational product administration over 48 hours. Efficacy will be assessed using 11-point numeric rating scale (NRS). Participants' safety will be monitored throughout the study. ;

Study Design

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

Related Conditions & MeSH terms

• Pain, Postoperative

• NCT number: NCT01814878
• Study type: Interventional
• Source: Janssen Korea, Ltd., Korea
• Status: Completed
• Phase: Phase 3
• Start date: November 2009
• Completion date: February 2011