Safety and Efficacy of Celecoxib Versus Naproxen in the 6-month Treatment of Knee Osteoarthritis

NCT ID: NCT00643799

Last Updated: 2021-02-02

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

586 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-01-31

Brief Summary

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To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis

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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A

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

200 mg oral capsule once daily for 6 months

B

Group Type ACTIVE_COMPARATOR

Naproxen

Intervention Type DRUG

500 mg oral capsule twice daily for 6 months

C

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matched oral placebo for 6 months

Interventions

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Celecoxib

200 mg oral capsule once daily for 6 months

Intervention Type DRUG

Naproxen

500 mg oral capsule twice daily for 6 months

Intervention Type DRUG

Placebo

Matched oral placebo for 6 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit
* Functional Capacity Classification of I-III

Exclusion Criteria

* Inflammatory arthritis or gout/pseudo-gout with an acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
* Received acetaminophen within 24 hours of the baseline visit
* Acute joint trauma at index joint within the past 3 months with active symptoms
* History of gastrointestinal (GI) perforation, obstruction, or bleeding
* Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
* Received corticosteroids or hyaluronic acid within certain timeframe before study
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

Montgomery, Alabama, United States

Site Status

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Phoenix, Arizona, United States

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Tempe, Arizona, United States

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Buena Park, California, United States

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Paramount, California, United States

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Rancho Mirage, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Washington D.C., District of Columbia, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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Zephyrhills, Florida, United States

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Rockford, Illinois, United States

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Wichita, Kansas, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Lexington, Kentucky, United States

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Covington, Louisiana, United States

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Metairie, Louisiana, United States

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Clinton, Maryland, United States

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Greenbelt, Maryland, United States

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Hagerstown, Maryland, United States

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Wheaton, Maryland, United States

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Milford, Massachusetts, United States

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Lansing, Michigan, United States

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Flowood, Mississippi, United States

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Kansas City, Missouri, United States

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Lincoln, Nebraska, United States

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Lincoln, Nebraska, United States

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New York, New York, United States

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Beachwood, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Bethlehem, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Media, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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San Angelo, Texas, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, 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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A3191152

Identifier Type: -

Identifier Source: org_study_id

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