Safety and Efficacy of Celecoxib Versus Placebo in the Treatment of Knee Osteoarthritis in Patients Who Were Unresponsive to Naproxen and Ibuprofen

Condition(s) targeted: Osteoarthritis, Knee

Intervention: Celecoxib (Drug); Placebo (Other)

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 efficacy and safety of celecoxib versus placebo for the treatment of knee osteoarthritis (OA) in patients who were unresponsive to prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen

Official title: A Double-Blind, Placebo Controlled Study of the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee Non-Responsive to Naproxen and Ibuprofen

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

Primary outcome: Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS)

Secondary outcome:

Patient's Assessment of Arthritis Pain, according to VAS

The Western Ontario and McMaster Universities Osteoarthritis Index

Patient's and Physician's Global Assessment of Arthritis

The Medical Outcomes Study Sleep Scale

Adverse events

Laboratory tests

Vital signs

Physical examination

Serious adverse events

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

Criteria:

Inclusion Criteria:

Inclusion criteria:

- Diagnosed, active, and symptomatic OA of the knee in a flare state with a functional

capacity class of I-III at baseline visit

- Failed adequate trials of both naproxen and ibuprofen (prescription strength) within

the past 5 years due to lack of efficacy, tolerability, or both; duration of prescription strength ibuprofen and naproxen must have been a minimum of 2 weeks for each drug at the respective recommended doses if failure was due to lack of efficacy, and for any duration if failure was due to lack of tolerability

Exclusion Criteria:

Exclusion criteria:

- Inflammatory arthritis or gout/pseudo-gout with 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

- Use of a mobility assisting device for less than six weeks prior to study screening or

use of a walker

- 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, Birmingham, Alabama 35235, United States

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

Pfizer Investigational Site, Denver, Colorado 80204, United States

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

Pfizer Investigational Site, Zephyrhills, Florida 33540, United States

Pfizer Investigational Site, Longwood, Florida 32779, United States

Pfizer Investigational Site, Miami, Florida 33186, United States

Pfizer Investigational Site, Boise, Idaho 83704, United States

Pfizer Investigational Site, Boise, Idaho 83706, United States

Pfizer Investigational Site, Morton Grove, Illinois 60053, United States

Pfizer Investigational Site, Wichita, Kansas 67206, United States

Pfizer Investigational Site, Wichita, Kansas 67214, United States

Pfizer Investigational Site, Wheaton, Maryland 20902, United States

Pfizer Investigational Site, Springfield, Missouri 65807, United States

Pfizer Investigational Site, Bozeman, Montana 59715, United States

Pfizer Investigational Site, Trenton, New Jersey 08611, United States

Pfizer Investigational Site, Brooklyn, New York 11203, United States

Pfizer Investigational Site, Binghamton, New York 13901, United States

Pfizer Investigational Site, NEW YORK, New York 10022-1009, United States

Pfizer Investigational Site, Winston-Salem, North Carolina 27103, United States

Pfizer Investigational Site, Cary, North Carolina 27609, United States

Pfizer Investigational Site, Bismarck, North Dakota 58506, United States

Pfizer Investigational Site, EUGENE, Oregon 97401, United States

Pfizer Investigational Site, Portland, Oregon 97239, United States

Pfizer Investigational Site, Duncansville, Pennsylvania 16635-0909, United States

Pfizer Investigational Site, Johnstown, Pennsylvania 15904, United States

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

Pfizer Investigational Site, Charleston, South Carolina 29407, United States

Pfizer Investigational Site, New Tazewell, Tennessee 37825, United States

Pfizer Investigational Site, San Antonio, Texas 78229, United States

Pfizer Investigational Site, Norfolk, Virginia 23502, United States

Pfizer Investigational Site, Arlington, Virginia 22203, United States

Pfizer Investigational Site, Seattle, Washington 98166, United States

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

Starting date: December 2003
Ending date: July 2004
Last updated: March 12, 2008