Official Title: “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”

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.

Study Type: Interventional

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

Study Primary Completion Date: August 2004

Intervention(s) in this Clinical Trial

• Drug: valdecoxib
  • 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
• Drug: diclofenac
  • diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Patient Assessment of Pain - Visual Analogue Scale
  • Time Frame: Days 1-6
    Safety Issue?: No

Secondary Measures

• Physical examination
  • Time Frame: Screening and Day 6
    Safety Issue?: Yes
• Global Evaluation of Study Medication
  • Time Frame: Days 1-6
    Safety Issue?: No
• Consumption of Rescue Medication
  • Time Frame: Days 1-6
    Safety Issue?: No
• Modified Brief Pain Inventory - short form
  • Time Frame: Days 2-6
    Safety Issue?: No
• Adverse events
  • Time Frame: Days 1-6
    Safety Issue?: Yes
• Vital signs
  • Time Frame: Screening, Day 1, and Day 6
    Safety Issue?: Yes
• Effect on Pain Medication Questionnaire and Health Resource Utilization
  • Time Frame: Days 2-6
    Safety Issue?: No

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

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 October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00650598

Study ID Number: A3471039

ClinicalTrials.gov Identifier: NCT00650598

Health Authority: Malaysia: Ministry of Health

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