A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib And Diclofenac In Patients With A Sprained Ankle

A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib Vs. Diclofenac In Ankle Sprain

To determine whether valdecoxib 40 mg twice a day the first day and then 40mg once a day until Day 7, was at least as effective as diclofenac 75 mg twice a day for 7 days, in treating acute first or second degree ankle sprain. The study also compared valdecoxib and diclofenac with respect to time to onset of pain relief (measured after the first dose), tolerability (adverse events) and time to return to Normal Function/Activity, among other measures.

Study Overview

• Status: Completed
• Conditions: Pain; Sprains and Strains; Sprain
• Intervention / Treatment: Drug: valdecoxib; Drug: diclofenac

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Pfizer Investigational Site
  • Buenos Aires
    • Avellaneda, Buenos Aires, Argentina, 1872
      • Pfizer Investigational Site
    • San Isidro, Buenos Aires, Argentina, 1642
      • Pfizer Investigational Site
• Chile
  • Santiago, Chile
    • Pfizer Investigational Site
  • RM
    • Santiago, RM, Chile
      • Pfizer Investigational Site
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, (574) 5141516
      • Pfizer Investigational Site
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, (57) 310-2322198
      • Pfizer Investigational Site
    • Bogota, Cundinamarca, Colombia, (57) 310-8849622
      • Pfizer Investigational Site
  • Cundinarmarca
    • Bogota, Cundinarmarca, Colombia, (571) 6 164278
      • Pfizer Investigational Site
  • Santander
    • Bucaramanga, Santander, Colombia, (577) 6 395409
      • Pfizer Investigational Site
  • Valle del Cauca
    • Cali, Valle del Cauca, Colombia, (57) 315-5410469
      • Pfizer Investigational Site
    • Calli, Valle del Cauca, Colombia, (57) 310-8259712
      • Pfizer Investigational Site
• Mexico
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Pfizer Investigational Site
• Peru
  • Lima, Peru, 27
    • Pfizer Investigational Site
  • Lima, Peru
    • Pfizer Investigational Site

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 sprained their ankle within 48 hours
• The sprain was a first or second degree ankle sprain of the lateral aspect, specifically: anterior talofibular ligament and/or calcaneofibular ligament
• At presentation patients were to have had moderate-severe ankle pain, (i.e., patient's assessment of ankle pain, on full weight bearing, using a 100 mm visual analog scale (VAS) was ≥ 45 mm), have a minimum rating of 2 on the Patient's Global Assessment of Ankle Injury and Patient's Assessment of Normal Function/Activity
• Investigator must have thought that the patient required and was eligible for therapy with an anti-inflammatory agent and/or analgesic to control symptoms

Exclusion Criteria:

• Women who were not post-menopausal or surgically sterilized, or who had have a positive urine pregnancy test prior to randomization and/or were not using adequate contraception according to the judgment of the Investigator
• Patients with a similar injury of the same joint within the last 6 months
• Clinical evidence of complete rupture of ankle ligaments (third degree sprain), required bed rest, hospitalization, surgical intervention for the ankle injury or non-removable full cast, bilateral occurrence of ankle injury or ankle and knee injury on the same side
• Patients with esophageal, gastric or duodenal ulcer within 30 days prior to randomization or had active GI or other disease that in the opinion of the investigator would preclude safe participation by the subject in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 2	Drug: diclofenac; diclofenac 75 mg capsule by mouth twice daily (BID) for 7 days
Active Comparator: Arm 1	Drug: valdecoxib; valdecoxib 40 mg tablet by mouth twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 7

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient's assessment of ankle pain VAS	Day 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to onset of pain relief	0, 15, 30, 45, and 60 minutes after first dose
Physician's global assessment of ankle injury	Days 1, 4, and 7
Patient's global assessment of ankle injury	Days 1, 4 and 7
Patient's assessment of normal function/activity	Days 1 to 7
Patient's and physician's satisfaction assessments	Day 7
Patient's assessment of ankle pain on visual analogue scale (VAS)	Days 1 to 7

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: December 1, 2002
• Study Completion (Actual): October 1, 2003

Study Registration Dates

• First Submitted: March 31, 2008
• First Submitted That Met QC Criteria: April 30, 2008
• First Posted (Estimate): May 5, 2008

Study Record Updates

• Last Update Posted (Estimate): May 5, 2008
• Last Update Submitted That Met QC Criteria: April 30, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Keywords: acute ankle sprain, acute pain, South America
• Additional Relevant MeSH Terms: Wounds and Injuries; Sprains and Strains; 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; Diclofenac; Valdecoxib
• Other Study ID Numbers: VALA-0513-146; A3471037