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An Efficacy and Safety Study of Periarticular Parecoxib Sodium for Pain Management in Total Knee Arthroplasty

NCT01311804 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2011-03-10

No results posted yet for this study

Summary

Primary Research Objective:

The primary objective of this study is to determine efficacy of periarticular parecoxib sodium in a multimodal cocktail versus intravenous parecoxib injections for pain management in total knee arthroplasty

Secondary Research Objective:

* To determine if perioperative use of parecoxib sodium was associated with improved clinical outcomes
* To evaluate the safety, in terms of adverse events; serious adverse events and tolerability of parecoxib sodium in periarticular injections in a multimodal cocktail

Conditions

  • Unilateral Primary Osteoarthritis of Knee

Interventions

PROCEDURE

parecoxib sodium

periarticular parecoxib sodium injection will be given during total knee arthroplasty

PROCEDURE

parecoxib sodium

intravenous parecoxib sodium during total knee arthroplasty

Sponsors & Collaborators

  • Ministry of Health, Malaysia

    lead OTHER_GOV

Principal Investigators

  • Yeap Ewe Juan · MOH Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-04-30
Completion
2011-10-31

Countries

  • Malaysia

Study Locations

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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 NCT01311804 on ClinicalTrials.gov