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

A Double-blind, Double-dummy, Multicenter Randomized Study Of The Efficacy And The Tolerability Of Valdecoxib 40mg Vs Rofecoxib 50mg In The Symptomatic Treatment Of Patients With Ankle Sprain

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.

Study Overview

• Status: Terminated
• Conditions: Acute Pain
• Intervention / Treatment: Drug: valdecoxib; Drug: rofecoxib

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04063003
    • Unifesp - Hsp
  • São Paulo, Brazil, 05001000
    • SECONCI
  • Goias
    • Goiania, Goias, Brazil, 74210-030
      • Instituto Ortopedico de Goiania
  • Goiás
    • Goiania, Goiás, Brazil
      • Centro de Traumatologia e Ortopedia
  • RIO Grande DO SUL
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90880480
      • Hospital Mae de Deus
  • RJ
    • Rio de Janeiro, RJ, Brazil
      • Hospital Sao Zacarias
  • RS
    • Porto Alegre, RS, Brazil, 91350200
      • Grupo Hospitalar Conceição
  • SP
    • São Paulo, SP, Brazil, 04822-320
      • Hospital Geral do Grajau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 2	Drug: rofecoxib; rofecoxib 50 mg (two 25 mg capsules) by mouth once daily for 8 days
Active Comparator: Arm 1	Drug: valdecoxib; valdecoxib 80 mg (two 40 mg tablets) by mouth on Day 1 and valdecoxib 40 mg tablet once daily on Days 2-8

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change from baseline in visual analogue scale (VAS) pain intensity	Day 4

Secondary Outcome Measures

Outcome Measure	Time Frame
patient's assessment of ankle pain VAS (0-100 mm)	Days 1, 4 and 8
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
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2003
• Primary Completion (Actual): October 1, 2004
• Study Completion (Actual): October 5, 2004

Study Registration Dates

• First Submitted: March 31, 2008
• First Submitted That Met QC Criteria: April 8, 2008
• First Posted (Estimate): April 14, 2008

Study Record Updates

• Last Update Posted (Actual): November 30, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: sprains and strains
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Acute Pain; Sprains and Strains; Ankle Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Valdecoxib; Rofecoxib
• Other Study ID Numbers: A3471007