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

June 3, 2008 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
488

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1T2
        • Pfizer Investigational Site
      • Kelowna, British Columbia, Canada, V1Y 3C8
        • Pfizer Investigational Site
      • Kelowna, British Columbia, Canada, V1Y 4V5
        • Pfizer Investigational Site
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Pfizer Investigational Site
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J4
        • Pfizer Investigational Site
      • Ajax, Ontario, Canada, L1S 2J5
        • Pfizer Investigational Site
      • Ajax, Ontario, Canada, L1S 7K8
        • Pfizer Investigational Site
      • Kingston, Ontario, Canada, K7L 2V7
        • Pfizer Investigational Site
      • Kingston, Ontario, Canada, K7L 5G2
        • Pfizer Investigational Site
      • Scarborough, Ontario, Canada, M1E 4B9
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M3M 2C2
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5T 2S8
        • Pfizer Investigational Site
      • Weston, Ontario, Canada, M9N 1N8
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 36205
        • Pfizer Investigational Site
      • Northport, Alabama, United States, 35476
        • Pfizer Investigational Site
    • Arizona
      • Glendale, Arizona, United States, 85310
        • Pfizer Investigational Site
      • Pheonix, Arizona, United States, 85006
        • Pfizer Investigational Site
      • Pheonix, Arizona, United States, 85008
        • Pfizer Investigational Site
      • Pheonix, Arizona, United States, 85016
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85016
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85032
        • Pfizer Investigational Site
      • Tempe, Arizona, United States, 85281
        • Pfizer Investigational Site
    • California
      • Glendale, California, United States, 91206
        • Pfizer Investigational Site
      • Laguna Hills, California, United States, 92653
        • Pfizer Investigational Site
      • Laguna Woods, California, United States, 92653
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90045
        • Pfizer Investigational Site
    • Connecticut
      • Avon, Connecticut, United States, 06001
        • Pfizer Investigational Site
      • Cromwell, Connecticut, United States, 06416
        • Pfizer Investigational Site
      • Enfield, Connecticut, United States, 06082
        • Pfizer Investigational Site
      • Farmington, Connecticut, United States, 06032
        • Pfizer Investigational Site
      • Farmington, Connecticut, United States, 06030
        • Pfizer Investigational Site
      • Glastonbury, Connecticut, United States, 06033
        • Pfizer Investigational Site
      • Hartford, Connecticut, United States, 06102
        • Pfizer Investigational Site
      • Hartford, Connecticut, United States, 06106
        • Pfizer Investigational Site
      • Rocky Hill, Connecticut, United States, 06067
        • Pfizer Investigational Site
      • Windsor, Connecticut, United States, 06095
        • Pfizer Investigational Site
    • Florida
      • Hollywood, Florida, United States, 33021
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32250
        • Pfizer Investigational Site
      • Plantation, Florida, United States, 33324
        • Pfizer Investigational Site
      • St. Augustine, Florida, United States, 32086
        • Pfizer Investigational Site
      • St. Petersburg, Florida, United States, 33703
        • Pfizer Investigational Site
      • Weston, Florida, United States, 33326
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Pfizer Investigational Site
      • Morrow, Georgia, United States, 30260
        • Pfizer Investigational Site
      • Stockbridge, Georgia, United States, 30281
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60304
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60612
        • Pfizer Investigational Site
      • Oak Park, Illinois, United States, 60304
        • Pfizer Investigational Site
    • Iowa
      • Cedar Rapids, Iowa, United States, 52401
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Pfizer Investigational Site
      • Lexington, Kentucky, United States, 40509
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Pfizer Investigational Site
      • Timonium, Maryland, United States, 21093
        • Pfizer Investigational Site
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Pfizer Investigational Site
      • Troy, Michigan, United States, 48085
        • Pfizer Investigational Site
    • Missouri
      • Springfield, Missouri, United States, 65804
        • Pfizer Investigational Site
      • Springfield, Missouri, United States, 65807
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89117
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89121
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89144
        • Pfizer Investigational Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • Pfizer Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Pfizer Investigational Site
      • Cola, South Carolina, United States, 29212
        • Pfizer Investigational Site
      • Columbia, South Carolina, United States, 29202
        • Pfizer Investigational Site
      • Columbia, South Carolina, United States, 29204
        • Pfizer Investigational Site
      • Orangeburg, South Carolina, United States, 29110
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site
      • Fort Worth, Texas, United States, 76104
        • Pfizer Investigational Site
      • Fort Worth, Texas, United States, 76107
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78217
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78127
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78209
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78240
        • Pfizer Investigational Site
      • San Marcos, Texas, United States, 78666
        • Pfizer Investigational Site
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Pfizer Investigational Site
      • Fairfax, Virginia, United States, 22031
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm 2
Drug: 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.
Drug: 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.
Active Comparator: Arm 1
Drug: 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.
Drug: 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.
Placebo Comparator: Arm 3
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Summed Pain Intensity (categorical) through 24 hours (SPI 24)
Time Frame: Day 2 and Day 3
Day 2 and Day 3
Patient's Global Evaluation of Study Medication (PGESM)
Time Frame: Day 2 and Day 3
Day 2 and Day 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Average Pain Intensity (derived from the mBPI-sf) on each study day
Time Frame: Days 2 to 5
Days 2 to 5
Worst Pain Intensity (derived from the Modified Brief Pain Inventory Short Form [mBPI-sf]) on each study day
Time Frame: Days 2 to 5
Days 2 to 5
Symptom Distress Scale Questionnaire
Time Frame: Days 2 to 5
Days 2 to 5
Patient Satisfaction Questionnaire for each study day
Time Frame: Days 2 to 5
Days 2 to 5
Time-specific pain intensity (PI) (categorical) on each study day
Time Frame: Days 2 to 5
Days 2 to 5
SPI 24 (Visual Analog Scale [VAS]) on each study day
Time Frame: Days 2 to 5
Days 2 to 5
Time-specific PI (VAS) on each study day
Time Frame: Days 2 to 5
Days 2 to 5
Patient's Global Evaluation of Study Medication
Time Frame: Day 4 and Day 5
Day 4 and Day 5
Time to first dose of rescue medication (supplemental analgesia) on each study day
Time Frame: Days 2 to 5
Days 2 to 5
Percent of subjects who took rescue medication (supplemental analgesia) on each study day
Time Frame: Days 2 to 5
Days 2 to 5
Amount of rescue medication (supplemental analgesia) taken on each study day
Time Frame: Days 2 to 5
Days 2 to 5
Individual and Composite Pain Interference With Function score (derived from the mBPI-sf) on each day
Time Frame: Days 2 to 5
Days 2 to 5
Time between doses of study medication on each study day
Time Frame: Days 2 to 5
Days 2 to 5
Post-Discharge Recovery Experience for each study day
Time Frame: Days 2 to 5
Days 2 to 5
SPI 24 (categorical)
Time Frame: Day 4 and Day 5
Day 4 and Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2004

Primary Completion

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 7, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A3471109

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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