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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2013-06-20

Study results available
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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.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Tramadol HCl/Acetaminophen ER

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

DRUG

Tramadol HCl/Acetaminophen IR

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

Sponsors & Collaborators

  • Janssen Korea, Ltd., Korea

    lead INDUSTRY

Principal Investigators

  • Janssen Korea Ltd. Clinical Trial · Janssen Korea Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-01-31
Completion
2011-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01814878 on ClinicalTrials.gov