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

Condition(s) targeted: Osteoarthritis, Knee

Intervention: Celecoxib (Drug); Naproxen (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

Official title: A Randomized, Multicenter, Double-Blind, Double-Dummy Study Comparing the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Naproxen 500 mg Twice Daily in the 6-Month Treatment of Subjects With Osteoarthritis of the Knee

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

Number of health care professional contacts

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

Change in WOMAC Total Score from baseline

Change in WOMAC Subscales from baseline

Response in each WOMAC Subscale

Change in Medical Outcome Study sleep scale from baseline

Laboratory tests

Vital signs

Response in VAS

Change in Patient's and Physician's Global Assessment of Pain from baseline

Change in visual analog scale (VAS) from baseline

Adverse events

Change in Gastrointestinal (GI) Distress Scale from Week 1

Change in GI Distress Scale from time of discontinuation of study drug

Receipt of prescription or over-the-counter gastroprotective agents or pain medications (off study drug)

Number of hospitalizations, emergency room visits, and procedures

Change in Work Limitation Questionnaire scale scores from baseline

Physical examination

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Pfizer Investigational Site, Montgomery, Alabama 36106, United States

Pfizer Investigational Site, Tempe, Arizona 85282, United States

Pfizer Investigational Site, PHOENIX, Arizona 85014, United States

Pfizer Investigational Site, Rancho Mirage, California 92270, United States

Pfizer Investigational Site, San Diego, California 92103, United States

Pfizer Investigational Site, PARAMOUNT, California 90723, United States

Pfizer Investigational Site, San Diego, California 92108, United States

Pfizer Investigational Site, Buena Park, California 90620, United States

Pfizer Investigational Site, Denver, Colorado 80230, United States

Pfizer Investigational Site, Washington, District of Columbia 20006, United States

Pfizer Investigational Site, OCALA, Florida 34474, United States

Pfizer Investigational Site, Tampa, Florida 33614, United States

Pfizer Investigational Site, Pembroke Pines, Florida 33024, United States

Pfizer Investigational Site, Clearwater, Florida 33761, United States

Pfizer Investigational Site, Orlando, Florida 32804, United States

Pfizer Investigational Site, DELAND, Florida 32720, United States

Pfizer Investigational Site, Jacksonville, Florida 32204, United States

Pfizer Investigational Site, Zephyrhills, Florida 33542, United States

Pfizer Investigational Site, Miami, Florida 33186, United States

Pfizer Investigational Site, Rockford, Illinois 61103, United States

Pfizer Investigational Site, Wichita, Kansas 67207, United States

Pfizer Investigational Site, Wichita, Kansas 67212, United States

Pfizer Investigational Site, LEXINGTON, Kentucky 40515, United States

Pfizer Investigational Site, Lexington, Kentucky 40503, United States

Pfizer Investigational Site, Covington, Louisiana 70433, United States

Pfizer Investigational Site, Metairie, Louisiana 70006, United States

Pfizer Investigational Site, Wheaton, Maryland 20902, United States

Pfizer Investigational Site, Clinton, Maryland 20735, United States

Pfizer Investigational Site, GREENBELT, Maryland 20770, United States

Pfizer Investigational Site, Hagerstown, Maryland 21740, United States

Pfizer Investigational Site, MILFORD, Massachusetts 01757, United States

Pfizer Investigational Site, Lansing, Michigan 48910, United States

Pfizer Investigational Site, Flowood, Mississippi 39232, United States

Pfizer Investigational Site, KANSAS CITY, Missouri 64114, United States

Pfizer Investigational Site, Lincoln, Nebraska 68506, United States

Pfizer Investigational Site, Lincoln, Nebraska 68516, United States

Pfizer Investigational Site, NEW YORK, New York 10022, United States

Pfizer Investigational Site, COLUMBUS, Ohio 43124, United States

Pfizer Investigational Site, Beachwood, Ohio 44122, United States

Pfizer Investigational Site, Columbus, Ohio 43215, United States

Pfizer Investigational Site, Columbus, Ohio 43222, United States

Pfizer Investigational Site, Oklahoma City, Oklahoma 73103, United States

Pfizer Investigational Site, Bethlehem, Pennsylvania 18015, United States

Pfizer Investigational Site, DUNCANSVILLE, Pennsylvania 16635, United States

Pfizer Investigational Site, Duncansville, Pennsylvania 16635, United States

Pfizer Investigational Site, Media, Pennsylvania 19603, United States

Pfizer Investigational Site, WARWICK, Rhode Island 02886, United States

Pfizer Investigational Site, DALLAS, Texas 75235, United States

Pfizer Investigational Site, San Angelo, Texas 76904, United States

Pfizer Investigational Site, Austin, Texas 78705, United States

Pfizer Investigational Site, Salt Lake City, Utah 84121, United States

Pfizer Investigational Site, Salt Lake City, Utah 84109, United States

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

Starting date: March 2004
Ending date: January 2005
Last updated: April 22, 2008