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

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

Official Title
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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

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: valdecoxib
* Drug: rofecoxib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sprains and strains