Effect of Celecoxib Versus Placebo Before and After Knee Surgery on Overall Use of Analgesics After Surgery

February 18, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Double-Blind, Placebo-Controlled, Randomized Comparison Study of the Efficacy of Celebrex 400 mg Single Dose Pre and Celebrex 200 mg Post Ambulatory Arthroscopic Knee Surgery for Total Analgesic Use After Surgery

To compare total analgesic use at 24 hours after arthroscopic knee surgery in celecoxib-treated versus placebo-treated patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Phase 4

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Pfizer Investigational Site
    • Florida
      • Saint Petersburg, Florida, United States, 33713
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Pfizer Investigational Site
      • Timonium, Maryland, United States, 21093
        • Pfizer Investigational Site
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Pfizer Investigational Site
      • Springfield, Massachusetts, United States, 01199
        • Pfizer Investigational Site
      • Springfield, Massachusetts, United States, 01104
        • Pfizer Investigational Site
      • Springfield, Massachusetts, United States, 01109
        • Pfizer Investigational Site
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Pfizer Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29202
        • Pfizer Investigational Site
      • Columbia, South Carolina, United States, 29204
        • Pfizer Investigational Site
      • Columbia, South Carolina, United States, 29212
        • Pfizer Investigational Site
      • Orangeburg, South Carolina, United States, 29110
        • Pfizer Investigational Site
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • Pfizer Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78209
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78240
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78205
        • 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

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Inclusion criteria:

  • Diagnosed (or suspected to have) meniscus trauma of the knee requiring ambulatory arthroscopic knee surgery
  • Willing to participate in study for 36 hours and come to follow-up visit 7 days post surgery

Exclusion Criteria:

Exclusion criteria:

  • Osteoarthritis, inflammatory arthritis, or previous fracture of index joint
  • Received acetaminophen or low dose narcotic (vicodin/tylox) within 8 hours of surgery
  • Have received oral (4 weeks), intramuscular (2 months), intra-articular (3 months) or soft-tissue (2 months) injections of corticosteroids of the first dose of study medication or intra-artcular injections of hyaluronic acid in the index joint within 9 months of the first dose of study medication

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Celecoxib
400 mg oral capsule as single dose administered 1 hour prior to surgery and 200 mg oral capsule as single dose administered post surgery as needed
Placebo Comparator: B
Other: Placebo
Matched oral capsule administered 1 hour prior to surgery and matched oral capsule administered post surgery as needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total analgesic use (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Vital signs
Time Frame: Day 7
Day 7
Adverse events
Time Frame: Day 7
Day 7
Patient Assessment of Pain, according to visual analogue scale, after surgery at rest and flexion
Time Frame: 1, 2, 6, 8, 10, 12, 24, 36 hours
1, 2, 6, 8, 10, 12, 24, 36 hours
Time to analgesic use after surgery
Time Frame: 1, 2, 6, 8, 10, 12, 24, 36 hours
1, 2, 6, 8, 10, 12, 24, 36 hours
Number and percentage of patients taking HC/APAP after surgery
Time Frame: 1, 2, 6, 8, 10, 12, 24, 36 hours
1, 2, 6, 8, 10, 12, 24, 36 hours
Physical exam
Time Frame: Day 7
Day 7
Laboratory evaluation
Time Frame: Day 7
Day 7

Collaborators and Investigators

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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

January 1, 2004

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

March 4, 2008

First Submitted That Met QC Criteria

March 4, 2008

First Posted (Estimate)

March 12, 2008

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3191067

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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