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

NCT00650039 | Completed Phase 3

• 1 other identifier: A3471109
• Study Type: interventional
• Target: 488
• Locations: 2 countries
• Sites: 81

Brief Summary

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.

Conditions

Pain

Keywords

Post surgical pain; Anterior Cruciate ligament reconstruction; Arthroscopy; Perioperative pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• 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

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

Drug: valdecoxib

Arm 2

ACTIVE COMPARATOR

Drug: valdecoxib

Arm 3

PLACEBO COMPARATOR

Drug: placebo

Interventions

placebo DRUG

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.

Arm 3

valdecoxib DRUG

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.

Arm 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (81)

Pfizer Investigational Site

Birmingham, Alabama, 35205, United States

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Birmingham, Alabama, 36205, United States

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Northport, Alabama, 35476, United States

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Glendale, Arizona, 85310, United States

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Pheonix, Arizona, 85006, United States

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Pheonix, Arizona, 85008, United States

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Pheonix, Arizona, 85016, United States

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Phoenix, Arizona, 85016, United States

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Phoenix, Arizona, 85032, United States

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Tempe, Arizona, 85281, United States

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Glendale, California, 91206, United States

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Laguna Hills, California, 92653, United States

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Laguna Woods, California, 92653, United States

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Los Angeles, California, 90045, United States

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Avon, Connecticut, 06001, United States

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Cromwell, Connecticut, 06416, United States

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Enfield, Connecticut, 06082, United States

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Farmington, Connecticut, 06030, United States

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Farmington, Connecticut, 06032, United States

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Glastonbury, Connecticut, 06033, United States

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Hartford, Connecticut, 06102, United States

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Hartford, Connecticut, 06106, United States

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Rocky Hill, Connecticut, 06067, United States

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Windsor, Connecticut, 06095, United States

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Hollywood, Florida, 33021, United States

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Jacksonville, Florida, 32216, United States

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Jacksonville, Florida, 32250, United States

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Plantation, Florida, 33324, United States

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Saint Augustine, Florida, 32086, United States

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St. Petersburg, Florida, 33703, United States

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Weston, Florida, 33326, United States

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Atlanta, Georgia, 30327, United States

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Morrow, Georgia, 30260, United States

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Stockbridge, Georgia, 30281, United States

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Chicago, Illinois, 60304, United States

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Chicago, Illinois, 60612, United States

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Oak Park, Illinois, 60304, United States

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Cedar Rapids, Iowa, 52401, United States

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Lexington, Kentucky, 40504, United States

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Lexington, Kentucky, 40509, United States

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Baltimore, Maryland, 21218, United States

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Timonium, Maryland, 21093, United States

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Royal Oak, Michigan, 48073, United States

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Troy, Michigan, 48085, United States

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Springfield, Missouri, 65804, United States

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Springfield, Missouri, 65807, United States

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Las Vegas, Nevada, 89106, United States

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Las Vegas, Nevada, 89117, United States

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Las Vegas, Nevada, 89121, United States

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Las Vegas, Nevada, 89144, United States

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Bend, Oregon, 97701, United States

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Anderson, South Carolina, 29621, United States

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Cola, South Carolina, 29212, United States

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Columbia, South Carolina, 29202, United States

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Columbia, South Carolina, 29204, United States

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Orangeburg, South Carolina, 29110, United States

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Austin, Texas, 78705, United States

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Dallas, Texas, 75231, United States

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Fort Worth, Texas, 76104, United States

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Fort Worth, Texas, 76107, United States

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San Antonio, Texas, 78127, United States

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San Antonio, Texas, 78209, United States

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San Antonio, Texas, 78217, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78240, United States

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San Marcos, Texas, 78666, United States

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Arlington, Virginia, 22205, United States

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Fairfax, Virginia, 22031, United States

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Kelowna, British Columbia, V1Y 1T2, Canada

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Kelowna, British Columbia, V1Y 3C8, Canada

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Kelowna, British Columbia, V1Y 4V5, Canada

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Vancouver, British Columbia, V6Z 1Y6, Canada

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Ajax, Ontario, L1S 2J4, Canada

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Ajax, Ontario, L1S 2J5, Canada

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Ajax, Ontario, L1S 7K8, Canada

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Kingston, Ontario, K7L 2V7, Canada

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Kingston, Ontario, K7L 5G2, Canada

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Scarborough Village, Ontario, M1E 4B9, Canada

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Toronto, Ontario, M3M 2C2, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Weston, Ontario, M9N 1N8, Canada

Location

Related Links

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

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

valdecoxib

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 28, 2008
• First Posted: April 1, 2008
• Study Start: March 1, 2004
• Study Completion: February 1, 2005
• Last Updated: June 4, 2008

Record last verified: 2008-03

Locations

US (68); CA (13)