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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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: placebo (Drug); valdecoxib (Drug); valdecoxib (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

Primary outcome:

Summed Pain Intensity (categorical) through 24 hours (SPI 24)

Patient's Global Evaluation of Study Medication (PGESM)

Secondary outcome:

Average Pain Intensity (derived from the mBPI-sf) on each study day

Worst Pain Intensity (derived from the Modified Brief Pain Inventory Short Form [mBPI-sf]) on each study day

Symptom Distress Scale Questionnaire

Patient Satisfaction Questionnaire for each study day

Time-specific pain intensity (PI) (categorical) on each study day

SPI 24 (Visual Analog Scale [VAS]) on each study day

Time-specific PI (VAS) on each study day

Patient's Global Evaluation of Study Medication

Time to first dose of rescue medication (supplemental analgesia) on each study day

Percent of subjects who took rescue medication (supplemental analgesia) on each study day

Amount of rescue medication (supplemental analgesia) taken on each study day

Individual and Composite Pain Interference With Function score (derived from the mBPI-sf) on each day

Time between doses of study medication on each study day

Post-Discharge Recovery Experience for each study day

SPI 24 (categorical)

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Locations and Contacts

Pfizer Investigational Site, Birmingham, Alabama 35205, United States

Pfizer Investigational Site, Birmingham, Alabama 36205, United States

Pfizer Investigational Site, Northport, Alabama 35476, United States

Pfizer Investigational Site, Glendale, Arizona 85310, United States

Pfizer Investigational Site, Pheonix, Arizona 85008, United States

Pfizer Investigational Site, Pheonix, Arizona 85016, United States

Pfizer Investigational Site, Pheonix, Arizona 85006, United States

Pfizer Investigational Site, Phoenix, Arizona 85032, United States

Pfizer Investigational Site, Phoenix, Arizona 85016, United States

Pfizer Investigational Site, Tempe, Arizona 85281, United States

Pfizer Investigational Site, Kelowna, British Columbia V1Y 1T2, Canada

Pfizer Investigational Site, Kelowna, British Columbia V1Y 3C8, Canada

Pfizer Investigational Site, Kelowna, British Columbia V1Y 4V5, Canada

Pfizer Investigational Site, Vancouver, British Columbia V6Z 1Y6, Canada

Pfizer Investigational Site, Glendale, California 91206, United States

Pfizer Investigational Site, Laguna Hills, California 92653, United States

Pfizer Investigational Site, Laguna Woods, California 92653, United States

Pfizer Investigational Site, Los Angeles, California 90045, United States

Pfizer Investigational Site, Avon, Connecticut 06001, United States

Pfizer Investigational Site, Cromwell, Connecticut 06416, United States

Pfizer Investigational Site, Enfield, Connecticut 06082, United States

Pfizer Investigational Site, Farmington, Connecticut 06030, United States

Pfizer Investigational Site, Farmington, Connecticut 06032, United States

Pfizer Investigational Site, Glastonbury, Connecticut 06033, United States

Pfizer Investigational Site, Hartford, Connecticut 06102, United States

Pfizer Investigational Site, Hartford, Connecticut 06106, United States

Pfizer Investigational Site, Rocky Hill, Connecticut 06067, United States

Pfizer Investigational Site, Windsor, Connecticut 06095, United States

Pfizer Investigational Site, Hollywood, Florida 33021, United States

Pfizer Investigational Site, Jacksonville, Florida 32216, United States

Pfizer Investigational Site, Jacksonville, Florida 32250, United States

Pfizer Investigational Site, Plantation, Florida 33324, United States

Pfizer Investigational Site, St. Augustine, Florida 32086, United States

Pfizer Investigational Site, St. Petersburg, Florida 33703, United States

Pfizer Investigational Site, Weston, Florida 33326, United States

Pfizer Investigational Site, Atlanta, Georgia 30327, United States

Pfizer Investigational Site, Morrow, Georgia 30260, United States

Pfizer Investigational Site, Stockbridge, Georgia 30281, United States

Pfizer Investigational Site, Chicago, Illinois 60304, United States

Pfizer Investigational Site, Chicago, Illinois 60612, United States

Pfizer Investigational Site, Oak Park, Illinois 60304, United States

Pfizer Investigational Site, Cedar Rapids, Iowa 52401, United States

Pfizer Investigational Site, Lexington, Kentucky 40504, United States

Pfizer Investigational Site, Lexington, Kentucky 40509, United States

Pfizer Investigational Site, Baltimore, Maryland 21218, United States

Pfizer Investigational Site, Timonium, Maryland 21093, United States

Pfizer Investigational Site, Royal Oak, Michigan 48073, United States

Pfizer Investigational Site, Troy, Michigan 48085, United States

Pfizer Investigational Site, Springfield, Missouri 65804, United States

Pfizer Investigational Site, Springfield, Missouri 65807, United States

Pfizer Investigational Site, Las Vegas, Nevada 89117, United States

Pfizer Investigational Site, Las Vegas, Nevada 89121, United States

Pfizer Investigational Site, Las Vegas, Nevada 89144, United States

Pfizer Investigational Site, Las Vegas, Nevada 89106, United States

Pfizer Investigational Site, Ajax, Ontario L1S 2J4, Canada

Pfizer Investigational Site, Ajax, Ontario L1S 2J5, Canada

Pfizer Investigational Site, Ajax, Ontario L1S 7K8, Canada

Pfizer Investigational Site, Kingston, Ontario K7L 5G2, Canada

Pfizer Investigational Site, Kingston, Ontario K7L 2V7, Canada

Pfizer Investigational Site, Scarborough, Ontario M1E 4B9, Canada

Pfizer Investigational Site, Toronto, Ontario M3M 2C2, Canada

Pfizer Investigational Site, Toronto, Ontario M5T 2S8, Canada

Pfizer Investigational Site, Weston, Ontario M9N 1N8, Canada

Pfizer Investigational Site, Bend, Oregon 97701, United States

Pfizer Investigational Site, Anderson, South Carolina 29621, United States

Pfizer Investigational Site, Cola, South Carolina 29212, United States

Pfizer Investigational Site, Columbia, South Carolina 29204, United States

Pfizer Investigational Site, Columbia, South Carolina 29202, United States

Pfizer Investigational Site, Orangeburg, South Carolina 29110, United States

Pfizer Investigational Site, Austin, Texas 78705, United States

Pfizer Investigational Site, Dallas, Texas 75231, United States

Pfizer Investigational Site, Fort Worth, Texas 76104, United States

Pfizer Investigational Site, Fort Worth, Texas 76107, United States

Pfizer Investigational Site, San Antonio, Texas 78209, United States

Pfizer Investigational Site, San Antonio, Texas 78127, United States

Pfizer Investigational Site, San Antonio, Texas 78217, United States

Pfizer Investigational Site, San Antonio, Texas 78229, United States

Pfizer Investigational Site, San Antonio, Texas 78240, United States

Pfizer Investigational Site, San Marcos, Texas 78666, United States

Pfizer Investigational Site, Arlington, Virginia 22205, United States

Pfizer Investigational Site, Fairfax, Virginia 22031, United States

Additional Information

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

Starting date: March 2004
Last updated: June 3, 2008

Page last updated: August 20, 2015

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