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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2004

Interventions

  • 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

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

Clinical Trial Outcome Measures

Primary Measures

  • Patient Assessment of Pain – Visual Analogue Scale
    • Time Frame: Days 1-6

Secondary Measures

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

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer, Inc.
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.