Official Title: “A Double-Blind, Double-Dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg vs. Rofecoxib 50 mg 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 Type: Interventional

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

Study Primary Completion Date: October 2004

This study was terminated early on 30 September 2004 due to safety concerns around the continued usage of rofecoxib following the withdrawal of rofecoxib from worldwide markets by Merck & Co Inc.

Intervention(s) in this Clinical Trial

• 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
• Drug: rofecoxib
  • rofecoxib 50 mg (two 25 mg capsules) by mouth once daily for 8 days

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• change from baseline in visual analogue scale (VAS) pain intensity
  • Time Frame: Day 4
    Safety Issue?: No

Secondary Measures

• patient's assessment of ankle pain VAS (0-100 mm)
  • Time Frame: Days 1, 4 and 8
    Safety Issue?: No
• patient's and physician's global assessment of ankle injury
  • Time Frame: Days 1, 4 and 8
    Safety Issue?: No
• patient's and physician's satisfaction assessments
  • Time Frame: Day 8
    Safety Issue?: No
• patient's assessment of normal function/activity
  • Time Frame: Days 1, 4 and 8
    Safety Issue?: No
• adverse events, physical examinations, and baseline clinical laboratory values
  • Time Frame: Adverse Events: Days 1, 4 and 8; Physical examinations: days 1 and 8; Lab tests: day 1
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

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/NCT00657449

Study ID Number: A3471007

ClinicalTrials.gov Identifier: NCT00657449

Health Authority: Brazil: National Health Surveillance Agency

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

Link to ClinicalStudyResults.org posting: