Clinical trial NCT00650039: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Post surgical pain
Anterior Cruciate ligament reconstruction
Arthroscopy
Perioperative pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Summed Pain Intensity (categorical) through 24 hours (SPI 24)
timeFrame: Day 2 and Day 3
measure: Patient's Global Evaluation of Study Medication (PGESM)
timeFrame: Day 2 and Day 3
Secondary outcomes:
measure: Average Pain Intensity (derived from the mBPI-sf) on each study day
timeFrame: Days 2 to 5
measure: Worst Pain Intensity (derived from the Modified Brief Pain Inventory Short Form [mBPI-sf]) on each study day
timeFrame: Days 2 to 5
measure: Symptom Distress Scale Questionnaire
timeFrame: Days 2 to 5
measure: Patient Satisfaction Questionnaire for each study day
timeFrame: Days 2 to 5
measure: Time-specific pain intensity (PI) (categorical) on each study day
timeFrame: Days 2 to 5
measure: SPI 24 (Visual Analog Scale [VAS]) on each study day
timeFrame: Days 2 to 5
measure: Time-specific PI (VAS) on each study day
timeFrame: Days 2 to 5
measure: Patient's Global Evaluation of Study Medication
timeFrame: Day 4 and Day 5
measure: Time to first dose of rescue medication (supplemental analgesia) on each study day
timeFrame: Days 2 to 5
measure: Percent of subjects who took rescue medication (supplemental analgesia) on each study day
timeFrame: Days 2 to 5
measure: Amount of rescue medication (supplemental analgesia) taken on each study day
timeFrame: Days 2 to 5
measure: Individual and Composite Pain Interference With Function score (derived from the mBPI-sf) on each day
timeFrame: Days 2 to 5
measure: Time between doses of study medication on each study day
timeFrame: Days 2 to 5
measure: Post-Discharge Recovery Experience for each study day
timeFrame: Days 2 to 5
measure: SPI 24 (categorical)
timeFrame: Day 4 and Day 5
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Northport
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Pheonix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Pheonix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Pheonix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tempe
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
city: Laguna Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Laguna Woods
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Avon
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Cromwell
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Enfield
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Farmington
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Farmington
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Glastonbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Hartford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Hartford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Rocky Hill
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Windsor
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Plantation
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Augustine
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Weston
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Morrow
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Stockbridge
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Oak Park
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Cedar Rapids
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Timonium
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Royal Oak
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Troy
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Bend
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Anderson
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Cola
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Orangeburg
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Marcos
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Fairfax
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Ajax
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ajax
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ajax
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Scarborough
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Weston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: