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Etoricoxib in Acute Ankle Ligament Sprains

NCT00954785 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2013-06-20

No results posted yet for this study

Summary

The aim of the study is to measure the effectiveness of treatment over 7 days with commonly used anti-inflammatory medications namely etoricoxib and diclofenac (Voltaren) on reducing the severity of pain, swelling and loss of function (range of movement, proprioception) arising from a mild to moderate sprain (partial tear) of the lateral (outer) ligaments of the ankle joint. This injury is commonly known as an ankle sprain.

Conditions

  • Sprain

Interventions

DEVICE

Ankle brace

Sports Stirrup ankle brace (Aircast)

DRUG

Diclofenac 50 mg tds

In the diclofenac group, each subject will receive 50 mg diclofenac in the morning, at mid-day and in the evening

DRUG

Etoricoxib 120 mg mane

In the etoricoxib group, each subject will receive 120 mg etoricoxib in the morning, and placebo medication in the evening and at mid-day

Sponsors & Collaborators

Principal Investigators

  • Martin P Schwellnus, MBBCh, MD · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-12-31
Completion
2011-07-31

Countries

  • South Africa

Study Locations

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Entities

Companies

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 NCT00954785 on ClinicalTrials.gov