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

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 Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: valdecoxib; Drug: diclofenac

• Study Type: Interventional
• Enrollment (Actual): 328
• Phase: Phase 4

Contacts and Locations

Study Locations

• • • Pfizer Investigational Site
• Australia
  • South Australia
    • Adelaide, South Australia, Australia, SA 5000
      • Pfizer Investigational Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Pfizer Investigational Site
  • Shatin, New Territories, Hong Kong
    • Pfizer Investigational Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 110-744
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 140-757
    • Pfizer Investigational Site
• Malaysia
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • Pfizer Investigational Site
  • Wilayah Persekutuan
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586
      • Pfizer Investigational Site
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
      • Pfizer Investigational Site
• New Zealand
  • Auckland, New Zealand
    • Pfizer Investigational Site
  • Christchurch, New Zealand
    • Pfizer Investigational Site
  • Wellington, New Zealand
    • Pfizer Investigational Site
• Philippines
  • Manila, Philippines
    • Pfizer Investigational Site
  • Quezon, Philippines
    • Pfizer Investigational Site
  • Quezon City, Philippines
    • Pfizer Investigational Site
• Singapore
  • Singapore, Singapore, 529889
    • Pfizer Investigational Site
• Taiwan
  • Kaohsiung, Taiwan
    • Pfizer Investigational Site
  • Keelung, Taiwan
    • Pfizer Investigational Site
  • Taipei, Taiwan
    • Pfizer Investigational Site
• Thailand
  • Bangkok, Thailand, 10330
    • Pfizer Investigational Site
  • Bangkok, Thailand, 10400
    • Pfizer Investigational Site
  • Bangkok, Thailand, 10700
    • Pfizer Investigational Site
  • Bangkok, Thailand
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Arm 2	Drug: diclofenac; diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days
ACTIVE_COMPARATOR: Arm 1	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (ACTUAL): August 1, 2004
• Study Completion (ACTUAL): August 1, 2004

Study Registration Dates

• First Submitted: March 31, 2008
• First Submitted That Met QC Criteria: April 1, 2008
• First Posted (ESTIMATE): April 2, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 8, 2008
• Last Update Submitted That Met QC Criteria: October 6, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: anterior cruciate ligament, arthroscopy, knee, post-surgical pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Diclofenac; Valdecoxib
• Other Study ID Numbers: A3471039