A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy for Anterior Cruciate Ligament (ACL) Reconstruction

Study Overview
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Brief Summary
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To demonstrate non-inferiority of valdecoxib 20 mg twice daily (BID) (with an initial loading dose of 40 mg followed by a second dose of 20 mg on the first day only) with diclofenac sodium delayed release 75 mg BID in analgesic efficacy, in subjects undergoing knee arthroscopy procedure for anterior cruciate ligament (ACL) reconstruction, when administered for 6 (±1) days.

Official Title
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A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy Procedure for Anterior Cruciate Ligament Reconstruction

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: valdecoxib
* Drug: diclofenac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who had undergone an uncomplicated ACL reconstruction procedure and were in satisfactory health were included in the study In addition, they needed to have a baseline pain intensity of ≥ 50 mm on the VAS and moderate to severe pain on the categorical scale within 8 hours of the completion of the surgical procedure to be included Exclusion Criteria: Patient was scheduled to undergo any other surgical procedure, along with the orthopedic procedure, that was expected to produce a greater degree of surgical trauma than the orthopedic procedure alone The patient was undergoing bilateral knee arthroscopy The patient used conventional NSAIDs, COX-2 inhibitors, or Tramadol during the 6 hours preceding surgery, during surgery or subsequent to the end of surgery, until randomization The patient received oxaprozin or piroxicam within one week prior to randomization The patient was required to take muscle relaxants, tricyclic antidepressants, tranquilizers, sedatives, hypnotics and neuroleptics, in the post operative period after the patient was randomized into the study The patient had been treated with patient controlled analgesia subsequent to the end of the surgical procedure

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 40 mg (two 20-mg tablets) loading dose by mouth on Day 1 followed by 20 mg twice daily (BID) on Days 2-6<br>|
| Active Comparator: Arm 2<br> | Drug: diclofenac<br>* diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Assessment of Pain - Visual Analogue Scale |  | Days 1-6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical examination |  | Screening and Day 6 | 
| Global Evaluation of Study Medication |  | Days 1-6 | 
| Consumption of Rescue Medication |  | Days 1-6 | 
| Modified Brief Pain Inventory - short form |  | Days 2-6 | 
| Adverse events |  | Days 1-6 | 
| Vital signs |  | Screening, Day 1, and Day 6 | 
| Effect on Pain Medication Questionnaire and Health Resource Utilization |  | Days 2-6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anterior cruciate ligament, arthroscopy, knee, post-surgical pain