Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (United States)

NCT ID: NCT00620867

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

393 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2003-03-31

Brief Summary

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To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ibuprofen

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

800 mg oral tablet three time daily with meals for 6 weeks

Celecoxib

Group Type EXPERIMENTAL

celecoxib

Intervention Type DRUG

200 mg oral capsule once daily with morning meal for 6 weeks

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

matched placebo orally for 6 weeks

Interventions

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Ibuprofen

800 mg oral tablet three time daily with meals for 6 weeks

Intervention Type DRUG

celecoxib

200 mg oral capsule once daily with morning meal for 6 weeks

Intervention Type DRUG

placebo

matched placebo orally for 6 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged \>= 40 years old
* Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit
* Functional capacity class of I-III

Exclusion Criteria

* Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
* Acute joint trauma at index joint within the past 3 months with active symptoms
* Score of \>=20 on PHQ-9 or score of \>=1 on PHQ-9 item i
* Use of mobility assisting device for \<6 weeks or use of walker
Minimum Eligible Age

40 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

Anniston, Alabama, United States

Site Status

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Phoenix, Arizona, United States

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Anaheim, California, United States

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Long Beach, California, United States

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Paramount, California, United States

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San Diego, California, United States

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DeLand, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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Pembroke Pines, Florida, United States

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St. Petersburg, Florida, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Las Vegas, Nevada, United States

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Edison, New Jersey, United States

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South Plainfield, New Jersey, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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New York, New York, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Tulsa, Oklahoma, United States

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Altoona, Pennsylvania, United States

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Jenkintown, Pennsylvania, United States

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Newtown, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Johnson City, Tennessee, United States

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Dallas, Texas, United States

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Layton, Utah, United States

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Danville, Virginia, United States

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Countries

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United States

Related Links

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Other Identifiers

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A3191063

Identifier Type: -

Identifier Source: org_study_id

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