Double-Blind, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg Daily And Valdecoxib 20 Mg Twice Daily Compared To Placebo For Management Of Acute Postsurgical Pain In Anterior Cruciate Ligament (ACL) Reconstruction

A Multicenter, Double-Blind, Placebo-Controlled, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg QD And Valdecoxib 20 Mg BID Compared To Placebo Over Multiple Days For Management Of Acute Postsurgical Pain In Patients Undergoing Anterior Cruciate Ligament Reconstruction

The primary objective was to evaluate the analgesic efficacy of valdecoxib 20 mg daily and valdecoxib 20 mg twice daily compared with placebo in outpatients with moderate-severe pain after arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. Secondary objectives were to compare each valdecoxib dose with placebo on additional measures of pain intensity, health outcomes, the use of rescue medication, and the occurrence of opioid-related symptoms, and to evaluate their safety.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: valdecoxib; Drug: valdecoxib; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 488
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 1T2
      • Pfizer Investigational Site
    • Kelowna, British Columbia, Canada, V1Y 3C8
      • Pfizer Investigational Site
    • Kelowna, British Columbia, Canada, V1Y 4V5
      • Pfizer Investigational Site
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Pfizer Investigational Site
  • Ontario
    • Ajax, Ontario, Canada, L1S 2J4
      • Pfizer Investigational Site
    • Ajax, Ontario, Canada, L1S 2J5
      • Pfizer Investigational Site
    • Ajax, Ontario, Canada, L1S 7K8
      • Pfizer Investigational Site
    • Kingston, Ontario, Canada, K7L 2V7
      • Pfizer Investigational Site
    • Kingston, Ontario, Canada, K7L 5G2
      • Pfizer Investigational Site
    • Scarborough, Ontario, Canada, M1E 4B9
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M3M 2C2
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M5T 2S8
      • Pfizer Investigational Site
    • Weston, Ontario, Canada, M9N 1N8
      • Pfizer Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Pfizer Investigational Site
    • Birmingham, Alabama, United States, 36205
      • Pfizer Investigational Site
    • Northport, Alabama, United States, 35476
      • Pfizer Investigational Site
  • Arizona
    • Glendale, Arizona, United States, 85310
      • Pfizer Investigational Site
    • Pheonix, Arizona, United States, 85006
      • Pfizer Investigational Site
    • Pheonix, Arizona, United States, 85008
      • Pfizer Investigational Site
    • Pheonix, Arizona, United States, 85016
      • Pfizer Investigational Site
    • Phoenix, Arizona, United States, 85016
      • Pfizer Investigational Site
    • Phoenix, Arizona, United States, 85032
      • Pfizer Investigational Site
    • Tempe, Arizona, United States, 85281
      • Pfizer Investigational Site
  • California
    • Glendale, California, United States, 91206
      • Pfizer Investigational Site
    • Laguna Hills, California, United States, 92653
      • Pfizer Investigational Site
    • Laguna Woods, California, United States, 92653
      • Pfizer Investigational Site
    • Los Angeles, California, United States, 90045
      • Pfizer Investigational Site
  • Connecticut
    • Avon, Connecticut, United States, 06001
      • Pfizer Investigational Site
    • Cromwell, Connecticut, United States, 06416
      • Pfizer Investigational Site
    • Enfield, Connecticut, United States, 06082
      • Pfizer Investigational Site
    • Farmington, Connecticut, United States, 06032
      • Pfizer Investigational Site
    • Farmington, Connecticut, United States, 06030
      • Pfizer Investigational Site
    • Glastonbury, Connecticut, United States, 06033
      • Pfizer Investigational Site
    • Hartford, Connecticut, United States, 06102
      • Pfizer Investigational Site
    • Hartford, Connecticut, United States, 06106
      • Pfizer Investigational Site
    • Rocky Hill, Connecticut, United States, 06067
      • Pfizer Investigational Site
    • Windsor, Connecticut, United States, 06095
      • Pfizer Investigational Site
  • Florida
    • Hollywood, Florida, United States, 33021
      • Pfizer Investigational Site
    • Jacksonville, Florida, United States, 32216
      • Pfizer Investigational Site
    • Jacksonville, Florida, United States, 32250
      • Pfizer Investigational Site
    • Plantation, Florida, United States, 33324
      • Pfizer Investigational Site
    • St. Augustine, Florida, United States, 32086
      • Pfizer Investigational Site
    • St. Petersburg, Florida, United States, 33703
      • Pfizer Investigational Site
    • Weston, Florida, United States, 33326
      • Pfizer Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30327
      • Pfizer Investigational Site
    • Morrow, Georgia, United States, 30260
      • Pfizer Investigational Site
    • Stockbridge, Georgia, United States, 30281
      • Pfizer Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60304
      • Pfizer Investigational Site
    • Chicago, Illinois, United States, 60612
      • Pfizer Investigational Site
    • Oak Park, Illinois, United States, 60304
      • Pfizer Investigational Site
  • Iowa
    • Cedar Rapids, Iowa, United States, 52401
      • Pfizer Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Pfizer Investigational Site
    • Lexington, Kentucky, United States, 40509
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Pfizer Investigational Site
    • Timonium, Maryland, United States, 21093
      • Pfizer Investigational Site
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Pfizer Investigational Site
    • Troy, Michigan, United States, 48085
      • Pfizer Investigational Site
  • Missouri
    • Springfield, Missouri, United States, 65804
      • Pfizer Investigational Site
    • Springfield, Missouri, United States, 65807
      • Pfizer Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Pfizer Investigational Site
    • Las Vegas, Nevada, United States, 89117
      • Pfizer Investigational Site
    • Las Vegas, Nevada, United States, 89121
      • Pfizer Investigational Site
    • Las Vegas, Nevada, United States, 89144
      • Pfizer Investigational Site
  • Oregon
    • Bend, Oregon, United States, 97701
      • Pfizer Investigational Site
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Pfizer Investigational Site
    • Cola, South Carolina, United States, 29212
      • Pfizer Investigational Site
    • Columbia, South Carolina, United States, 29202
      • Pfizer Investigational Site
    • Columbia, South Carolina, United States, 29204
      • Pfizer Investigational Site
    • Orangeburg, South Carolina, United States, 29110
      • Pfizer Investigational Site
  • Texas
    • Austin, Texas, United States, 78705
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75231
      • Pfizer Investigational Site
    • Fort Worth, Texas, United States, 76104
      • Pfizer Investigational Site
    • Fort Worth, Texas, United States, 76107
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78229
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78217
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78127
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78209
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78240
      • Pfizer Investigational Site
    • San Marcos, Texas, United States, 78666
      • Pfizer Investigational Site
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Pfizer Investigational Site
    • Fairfax, Virginia, United States, 22031
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Included patients had uncomplicated arthroscopic ACL reconstruction
• Subjects were to have a Baseline pain intensity of ≥ 50 mm as measured on a 0 - 100mm visual analogue scale (VAS) and moderate to severe pain on a categorical scale by 23:00 hours on the day of surgery and prior to being discharged from the surgical facility
• Subjects could not have received any medication or additional procedures that would confound the interpretation of the study results.

Exclusion Criteria:

• the patient was admitted to or retained in the surgical center/hospital for >23 hours;
• the patient underwent 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 used conventional nonsteroidal antiinflammatory drugs (NSAIDs), selective cyclooxygenase-2 (COX-2) inhibitors, or tramadol during the 6 hours preceding surgery, during surgery, or subsequent to the end of surgery;
• the patient received oxaprozin or piroxicam within 1 week prior to randomization;
• the patient had a pain pump or indwelling catheter during surgery that administered local or intraarticular anesthetics or narcotics at the index joint, or had such an intra-articular injection at the end of surgery;
• the patient had been treated with patient-controlled analgesia or NSAIDs subsequent to the end of anesthesia;
• patient had a history of clinically significant GI disease or renal disease, or history of a gastrointestinal ulcer, or cancer, or a laboratory abnormality that would suggest it was not in the subject's best interest to enroll in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 2	Drug: valdecoxib; valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg once daily (QD) by mouth on Days 2 to 5.; Drug: valdecoxib; valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg twice daily (BID) by mouth on Days 2 to 5.
Active Comparator: Arm 1	Drug: valdecoxib; valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg once daily (QD) by mouth on Days 2 to 5.; Drug: valdecoxib; valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg twice daily (BID) by mouth on Days 2 to 5.
Placebo Comparator: Arm 3	Drug: placebo; valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, placebo BID by mouth on Days 2 to 5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Summed Pain Intensity (categorical) through 24 hours (SPI 24)	Day 2 and Day 3
Patient's Global Evaluation of Study Medication (PGESM)	Day 2 and Day 3

Secondary Outcome Measures

Outcome Measure	Time Frame
Average Pain Intensity (derived from the mBPI-sf) on each study day	Days 2 to 5
Worst Pain Intensity (derived from the Modified Brief Pain Inventory Short Form [mBPI-sf]) on each study day	Days 2 to 5
Symptom Distress Scale Questionnaire	Days 2 to 5
Patient Satisfaction Questionnaire for each study day	Days 2 to 5
Time-specific pain intensity (PI) (categorical) on each study day	Days 2 to 5
SPI 24 (Visual Analog Scale [VAS]) on each study day	Days 2 to 5
Time-specific PI (VAS) on each study day	Days 2 to 5
Patient's Global Evaluation of Study Medication	Day 4 and Day 5
Time to first dose of rescue medication (supplemental analgesia) on each study day	Days 2 to 5
Percent of subjects who took rescue medication (supplemental analgesia) on each study day	Days 2 to 5
Amount of rescue medication (supplemental analgesia) taken on each study day	Days 2 to 5
Individual and Composite Pain Interference With Function score (derived from the mBPI-sf) on each day	Days 2 to 5
Time between doses of study medication on each study day	Days 2 to 5
Post-Discharge Recovery Experience for each study day	Days 2 to 5
SPI 24 (categorical)	Day 4 and Day 5

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion: December 7, 2022
• Study Completion (Actual): February 1, 2005

Study Registration Dates

• First Submitted: March 28, 2008
• First Submitted That Met QC Criteria: March 28, 2008
• First Posted (Estimate): April 1, 2008

Study Record Updates

• Last Update Posted (Estimate): June 4, 2008
• Last Update Submitted That Met QC Criteria: June 3, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: Post surgical pain; Anterior Cruciate ligament reconstruction; Arthroscopy; Perioperative 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; Valdecoxib
• Other Study ID Numbers: A3471109

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No