Official Title: “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 Type: Interventional

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

Intervention(s) in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 1
• Active Comparator: Arm 2
• Placebo Comparator: Arm 3

Primary Measures

• Summed Pain Intensity (categorical) through 24 hours (SPI 24)
  • Time Frame: Day 2 and Day 3
    Safety Issue?: No
• Patient's Global Evaluation of Study Medication (PGESM)
  • Time Frame: Day 2 and Day 3
    Safety Issue?: No

Secondary Measures

• Average Pain Intensity (derived from the mBPI-sf) on each study day
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• Worst Pain Intensity (derived from the Modified Brief Pain Inventory Short Form [mBPI-sf]) on each study day
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• Symptom Distress Scale Questionnaire
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• Patient Satisfaction Questionnaire for each study day
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• Time-specific pain intensity (PI) (categorical) on each study day
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• SPI 24 (Visual Analog Scale [VAS]) on each study day
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• Time-specific PI (VAS) on each study day
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• Patient's Global Evaluation of Study Medication
  • Time Frame: Day 4 and Day 5
    Safety Issue?: No
• Time to first dose of rescue medication (supplemental analgesia) on each study day
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• Percent of subjects who took rescue medication (supplemental analgesia) on each study day
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• Amount of rescue medication (supplemental analgesia) taken on each study day
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• Individual and Composite Pain Interference With Function score (derived from the mBPI-sf) on each day
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• Time between doses of study medication on each study day
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• Post-Discharge Recovery Experience for each study day
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• SPI 24 (categorical)
  • Time Frame: Day 4 and Day 5
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

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 November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00650039

Study ID Number: A3471109

ClinicalTrials.gov Identifier: NCT00650039

Health Authority: United States: Food and Drug Administration

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

Link to ClinicalStudyResults.org posting: