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

NCT00643799 | Completed Phase 4

• 1 other identifier: A3191152
• Study Type: interventional
• Target: 586
• Locations: 1 country
• Sites: 51

Brief Summary

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

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score

  Month 6

Secondary Outcomes (18)

• Number of health care professional contacts

  Throughout study

• Patient's and Physician's Satisfaction with Current Arthritis Therapy

  Month 6

• Change in WOMAC Total Score from baseline

  Month 6

• Change in WOMAC Subscales from baseline

  Month 6

• Response in each WOMAC Subscale

  Month 6

Study Arms (3)

A

EXPERIMENTAL

Drug: Celecoxib

B

ACTIVE COMPARATOR

Drug: Naproxen

C

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Celecoxib DRUG

200 mg oral capsule once daily for 6 months

A

Naproxen DRUG

500 mg oral capsule twice daily for 6 months

B

Placebo DRUG

Matched oral placebo for 6 months

C

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (51)

Pfizer Investigational Site

Montgomery, Alabama, 36106, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85014, United States

Location

Pfizer Investigational Site

Tempe, Arizona, 85282, United States

Location

Pfizer Investigational Site

Buena Park, California, 90620, United States

Location

Pfizer Investigational Site

Paramount, California, 90723, United States

Location

Pfizer Investigational Site

Rancho Mirage, California, 92270, United States

Location

Pfizer Investigational Site

San Diego, California, 92103, United States

Location

Pfizer Investigational Site

San Diego, California, 92108, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80230, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20006, United States

Location

Pfizer Investigational Site

Clearwater, Florida, 33761, United States

Location

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DeLand, Florida, 32720, United States

Location

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Jacksonville, Florida, 32204, United States

Location

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Miami, Florida, 33186, United States

Location

Pfizer Investigational Site

Ocala, Florida, 34474, United States

Location

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Orlando, Florida, 32804, United States

Location

Pfizer Investigational Site

Pembroke Pines, Florida, 33024, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33614, United States

Location

Pfizer Investigational Site

Zephyrhills, Florida, 33542, United States

Location

Pfizer Investigational Site

Rockford, Illinois, 61103, United States

Location

Pfizer Investigational Site

Wichita, Kansas, 67207, United States

Location

Pfizer Investigational Site

Wichita, Kansas, 67212, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40503, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40515, United States

Location

Pfizer Investigational Site

Covington, Louisiana, 70433, United States

Location

Pfizer Investigational Site

Metairie, Louisiana, 70006, United States

Location

Pfizer Investigational Site

Clinton, Maryland, 20735, United States

Location

Pfizer Investigational Site

Greenbelt, Maryland, 20770, United States

Location

Pfizer Investigational Site

Hagerstown, Maryland, 21740, United States

Location

Pfizer Investigational Site

Wheaton, Maryland, 20902, United States

Location

Pfizer Investigational Site

Milford, Massachusetts, 01757, United States

Location

Pfizer Investigational Site

Lansing, Michigan, 48910, United States

Location

Pfizer Investigational Site

Flowood, Mississippi, 39232, United States

Location

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Kansas City, Missouri, 64114, United States

Location

Pfizer Investigational Site

Lincoln, Nebraska, 68506, United States

Location

Pfizer Investigational Site

Lincoln, Nebraska, 68516, United States

Location

Pfizer Investigational Site

New York, New York, 10022, United States

Location

Pfizer Investigational Site

Beachwood, Ohio, 44122, United States

Location

Pfizer Investigational Site

Columbus, Ohio, 43124, United States

Location

Pfizer Investigational Site

Columbus, Ohio, 43215, United States

Location

Pfizer Investigational Site

Columbus, Ohio, 43222, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73103, United States

Location

Pfizer Investigational Site

Bethlehem, Pennsylvania, 18015, United States

Location

Pfizer Investigational Site

Duncansville, Pennsylvania, 16635, United States

Location

Pfizer Investigational Site

Media, Pennsylvania, 19603, United States

Location

Pfizer Investigational Site

Warwick, Rhode Island, 02886, United States

Location

Pfizer Investigational Site

Austin, Texas, 78705, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75235, United States

Location

Pfizer Investigational Site

San Angelo, Texas, 76904, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84109, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84121, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Celecoxib; Naproxen

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 26, 2008
• Study Start: March 1, 2004
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

US (51)