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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

Last Updated: 2008-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

488 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Keywords

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Post surgical pain Anterior Cruciate ligament reconstruction Arthroscopy Perioperative pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

valdecoxib

Intervention Type 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 twice daily (BID) by mouth on Days 2 to 5.

Arm 2

Group Type ACTIVE_COMPARATOR

valdecoxib

Intervention Type DRUG

Arm 3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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placebo

Intervention Type DRUG

valdecoxib

Intervention Type DRUG

valdecoxib

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Northport, Alabama, United States

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Glendale, Arizona, United States

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Pheonix, Arizona, United States

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Pheonix, Arizona, United States

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Pheonix, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tempe, Arizona, United States

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Glendale, California, United States

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Laguna Hills, California, United States

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Laguna Woods, California, United States

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Los Angeles, California, United States

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Avon, Connecticut, United States

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Cromwell, Connecticut, United States

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Enfield, Connecticut, United States

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Farmington, Connecticut, United States

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Farmington, Connecticut, United States

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Glastonbury, Connecticut, United States

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Hartford, Connecticut, United States

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Hartford, Connecticut, United States

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Rocky Hill, Connecticut, United States

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Windsor, Connecticut, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Plantation, Florida, United States

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Saint Augustine, Florida, United States

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St. Petersburg, Florida, United States

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Weston, Florida, United States

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Atlanta, Georgia, United States

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Morrow, Georgia, United States

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Stockbridge, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Oak Park, Illinois, United States

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Cedar Rapids, Iowa, United States

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Lexington, Kentucky, United States

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Lexington, Kentucky, United States

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Baltimore, Maryland, United States

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Timonium, Maryland, United States

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Royal Oak, Michigan, United States

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Troy, Michigan, United States

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Springfield, Missouri, United States

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Springfield, Missouri, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Bend, Oregon, United States

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Anderson, South Carolina, United States

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Cola, South Carolina, United States

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Columbia, South Carolina, United States

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Columbia, South Carolina, United States

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Orangeburg, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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