CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 320 enrolled
Drug / intervention
Tramadol HCl/Acetaminophen ER +1 moredrug
Likely dose
Tramadol HCl/Acetaminophen ER 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01814878
NCT01814878Phase 3Completed
CompareCT.gov

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

Janssen Korea, Ltd., Korea·interventional·Posted Mar 20, 2013·Updated Jun 20, 2013

In Brief

A Phase 3 clinical trial evaluating Tramadol HCl/Acetaminophen ER and Tramadol HCl/Acetaminophen IR for Pain, Postoperative. Completed, enrolled 320 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postoperative
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 20, 2013
Enrollment StartNov 1, 2009
Primary CompletionJan 1, 2011
Study CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.3 years ago

Interventions

Tramadol HCl/Acetaminophen ERdrug

2 tablets of ER (tramadol HCl \[75 mg\]/acetaminophen \[650 mg\]) will be administered at 0, 12, 24 and 36 hours

Tramadol HCl/Acetaminophen IRdrug

2 tablets of IR (tramadol HCl \[37.5 mg\]/acetaminophen \[325 mg\]) at 0, 6, 12, 18, 24, 30, 36 and 42 hours