Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: valdecoxib
  • valdecoxib 40 mg tablet by mouth twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 7
• Drug: diclofenac
  • diclofenac 75 mg capsule by mouth twice daily (BID) for 7 days

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 1
• Active Comparator: Arm 2

Primary Measures

• Patient's assessment of ankle pain VAS
  • Time Frame: Day 4
    Safety Issue?: No

Secondary Measures

• Time to onset of pain relief
  • Time Frame: 0, 15, 30, 45, and 60 minutes after first dose
    Safety Issue?: No
• Physician's global assessment of ankle injury
  • Time Frame: Days 1, 4, and 7
    Safety Issue?: No
• Patient's global assessment of ankle injury
  • Time Frame: Days 1, 4 and 7
    Safety Issue?: No
• Patient's assessment of normal function/activity
  • Time Frame: Days 1 to 7
    Safety Issue?: No
• Patient's and physician's satisfaction assessments
  • Time Frame: Day 7
    Safety Issue?: No
• Patient's assessment of ankle pain on visual analogue scale (VAS)
  • Time Frame: Days 1 to 7
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00671320

Study ID Number: VALA-0513-146

ClinicalTrials.gov Identifier: NCT00671320

Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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Link to ClinicalStudyResults.org posting: