A Double-blind, Double-dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg Versus Rofecoxib 50 mg in Treating the Symptoms of Ankle Sprain

Phase 4

Terminated

• Conditions: Acute Pain
• Interventions: Drug: valdecoxib; Drug: rofecoxib

• Registration Number: NCT00657449
• Lead Sponsor: Pfizer

Brief Summary

The study compares valdecoxib 40 mg once daily vs. rofecoxib 50 mg one daily in treating the signs and symptoms of acute first- or second-degree ankle sprain. The study also evaluated the disability status, tolerability and safety of these treatments.

Detailed Description

A3471007 terminated early (30Sep2004) due to safety concerns about continued usage of rofecoxib after worldwide withdrawal of rofecoxib by Merck \& Co Inc

Study Timeline

• Study Start: 2003-06-04
• Primary Completion: 2004-10-01
• Study Completion: 2004-10-05
• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-04-08
• Study First Posted: 2008-04-14
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Patients had sustained, no more than 48 hours prior to the first dose of study medication, a first- or second-degree ankle sprain of the lateral ligament, specifically: anterior talofibular ligament and/or posterior talofibular ligament and/or calcaneofibular ligament
• At presentation, all patients were to have Patient's Assessment of Ankle Pain Visual Analog Scale (VAS) (0-100mm) of ≥45 mm in the orthostatic position on full weight bearing (ie, moderate to severe pain), had a minimum rating of 2 on the Patient's Global Assessment of Ankle Injury and Patient's Assessment of Normal Function/Activity
• Tthe investigator opinion was that each patient required, and was eligible for, therapy with an anti-inflammatory agent and/or analgesics to control symptoms

Exclusion Criteria

None reported

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	valdecoxib	-
Arm 2	rofecoxib	-

Primary Outcome Measures

Name	Time	Method
change from baseline in visual analogue scale (VAS) pain intensity	Day 4

Secondary Outcome Measures

Name	Time	Method
patient's and physician's global assessment of ankle injury	Days 1, 4 and 8
patient's and physician's satisfaction assessments	Day 8
patient's assessment of normal function/activity	Days 1, 4 and 8
patient's assessment of ankle pain VAS (0-100 mm)	Days 1, 4 and 8
adverse events, physical examinations, and baseline clinical laboratory values	Adverse Events: Days 1, 4 and 8; Physical examinations: days 1 and 8; Lab tests: day 1

Trial Locations

Locations (8)

Instituto Ortopedico de Goiania; 🇧🇷 Goiania, Goias, Brazil

Grupo Hospitalar Conceiçao; 🇧🇷 Porto Alegre, RS, Brazil

Hospital Geral do Grajau; 🇧🇷 São Paulo, SP, Brazil

Unifesp - Hsp; 🇧🇷 São Paulo, Brazil

SECONCI; 🇧🇷 São Paulo, Brazil

Hospital Mãe de Deus; 🇧🇷 Porto Alegre, RIO Grande DO SUL, Brazil

Hospital Sao Zacarias; 🇧🇷 Rio de Janeiro, RJ, Brazil

Centro de Traumatologia e Ortopedia; 🇧🇷 Goiania, Goiás, Brazil