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NCT00650039 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00650039
Other study ID # A3471109
Secondary ID
Status Completed
Phase Phase 3
First received March 28, 2008
Last updated June 3, 2008
Start date March 2004
Est. completion date February 2005

Study information
Verified date March 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 488
Est. completion date February 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.
• 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.
• 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.

Locations
Country Name City State
Canada Pfizer Investigational Site Ajax Ontario
Canada Pfizer Investigational Site Ajax Ontario
Canada Pfizer Investigational Site Ajax Ontario
Canada Pfizer Investigational Site Kelowna British Columbia
Canada Pfizer Investigational Site Kelowna British Columbia
Canada Pfizer Investigational Site Kelowna British Columbia
Canada Pfizer Investigational Site Kingston Ontario
Canada Pfizer Investigational Site Kingston Ontario
Canada Pfizer Investigational Site Scarborough Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Vancouver British Columbia
Canada Pfizer Investigational Site Weston Ontario
United States Pfizer Investigational Site Anderson South Carolina
United States Pfizer Investigational Site Arlington Virginia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Avon Connecticut
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Bend Oregon
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Cedar Rapids Iowa
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Cola South Carolina
United States Pfizer Investigational Site Columbia South Carolina
United States Pfizer Investigational Site Columbia South Carolina
United States Pfizer Investigational Site Cromwell Connecticut
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Enfield Connecticut
United States Pfizer Investigational Site Fairfax Virginia
United States Pfizer Investigational Site Farmington Connecticut
United States Pfizer Investigational Site Farmington Connecticut
United States Pfizer Investigational Site Fort Worth Texas
United States Pfizer Investigational Site Fort Worth Texas
United States Pfizer Investigational Site Glastonbury Connecticut
United States Pfizer Investigational Site Glendale Arizona
United States Pfizer Investigational Site Glendale California
United States Pfizer Investigational Site Hartford Connecticut
United States Pfizer Investigational Site Hartford Connecticut
United States Pfizer Investigational Site Hollywood Florida
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Laguna Hills California
United States Pfizer Investigational Site Laguna Woods California
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Morrow Georgia
United States Pfizer Investigational Site Northport Alabama
United States Pfizer Investigational Site Oak Park Illinois
United States Pfizer Investigational Site Orangeburg South Carolina
United States Pfizer Investigational Site Pheonix Arizona
United States Pfizer Investigational Site Pheonix Arizona
United States Pfizer Investigational Site Pheonix Arizona
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Plantation Florida
United States Pfizer Investigational Site Rocky Hill Connecticut
United States Pfizer Investigational Site Royal Oak Michigan
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Marcos Texas
United States Pfizer Investigational Site Springfield Missouri
United States Pfizer Investigational Site Springfield Missouri
United States Pfizer Investigational Site St. Augustine Florida
United States Pfizer Investigational Site St. Petersburg Florida
United States Pfizer Investigational Site Stockbridge Georgia
United States Pfizer Investigational Site Tempe Arizona
United States Pfizer Investigational Site Timonium Maryland
United States Pfizer Investigational Site Troy Michigan
United States Pfizer Investigational Site Weston Florida
United States Pfizer Investigational Site Windsor Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Summed Pain Intensity (categorical) through 24 hours (SPI 24) Day 2 and Day 3 No
Primary Patient's Global Evaluation of Study Medication (PGESM) Day 2 and Day 3 No
Secondary Average Pain Intensity (derived from the mBPI-sf) on each study day Days 2 to 5 No
Secondary Worst Pain Intensity (derived from the Modified Brief Pain Inventory Short Form [mBPI-sf]) on each study day Days 2 to 5 No
Secondary Symptom Distress Scale Questionnaire Days 2 to 5 No
Secondary Patient Satisfaction Questionnaire for each study day Days 2 to 5 No
Secondary Time-specific pain intensity (PI) (categorical) on each study day Days 2 to 5 No
Secondary SPI 24 (Visual Analog Scale [VAS]) on each study day Days 2 to 5 No
Secondary Time-specific PI (VAS) on each study day Days 2 to 5 No
Secondary Patient's Global Evaluation of Study Medication Day 4 and Day 5 No
Secondary Time to first dose of rescue medication (supplemental analgesia) on each study day Days 2 to 5 No
Secondary Percent of subjects who took rescue medication (supplemental analgesia) on each study day Days 2 to 5 No
Secondary Amount of rescue medication (supplemental analgesia) taken on each study day Days 2 to 5 No
Secondary Individual and Composite Pain Interference With Function score (derived from the mBPI-sf) on each day Days 2 to 5 No
Secondary Time between doses of study medication on each study day Days 2 to 5 No
Secondary Post-Discharge Recovery Experience for each study day Days 2 to 5 No
Secondary SPI 24 (categorical) Day 4 and Day 5 No
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