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

NCT ID: NCT00633438

Last Updated: 2021-02-21

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

PHASE4

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2004-06-30

Brief Summary

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

Detailed Description

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Conditions

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Arthroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Matched oral capsule administered 1 hour prior to surgery and matched oral capsule administered post surgery as needed

A

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

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

Interventions

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Placebo

Matched oral capsule administered 1 hour prior to surgery and matched oral capsule administered post surgery as needed

Intervention Type OTHER

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

Intervention Type DRUG

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Phoenix, Arizona, United States

Site Status

Pfizer Investigational Site

St. Petersburg, Florida, United States

Site Status

Pfizer Investigational Site

Baltimore, Maryland, United States

Site Status

Pfizer Investigational Site

Timonium, Maryland, United States

Site Status

Pfizer Investigational Site

Springfield, Massachusetts, United States

Site Status

Pfizer Investigational Site

Springfield, Massachusetts, United States

Site Status

Pfizer Investigational Site

Springfield, Massachusetts, United States

Site Status

Pfizer Investigational Site

Springfield, Massachusetts, United States

Site Status

Pfizer Investigational Site

Springfield, Missouri, United States

Site Status

Pfizer Investigational Site

Columbia, South Carolina, United States

Site Status

Pfizer Investigational Site

Columbia, South Carolina, United States

Site Status

Pfizer Investigational Site

Columbia, South Carolina, United States

Site Status

Pfizer Investigational Site

Orangeburg, South Carolina, United States

Site Status

Pfizer Investigational Site

Johnson City, Tennessee, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A3191067

Identifier Type: -

Identifier Source: org_study_id

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