Safety and Efficacy of Celecoxib Versus Placebo in the Treatment of Knee Osteoarthritis in Patients Who Were Unresponsive to Naproxen and Ibuprofen
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
1 other identifier
interventional
388
1 country
33
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2003
Shorter than P25 for phase_4
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 12, 2008
CompletedFirst Posted
Study publicly available on registry
March 19, 2008
CompletedFebruary 2, 2021
January 1, 2021
March 12, 2008
January 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS)
Week 6
Secondary Outcomes (9)
Patient's Assessment of Arthritis Pain, according to VAS
Week 2
The Western Ontario and McMaster Universities Osteoarthritis Index
Week 6
Patient's and Physician's Global Assessment of Arthritis
Weeks 2 and 6
The Medical Outcomes Study Sleep Scale
Week 6
Adverse events
Weeks 0-6
- +4 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
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 D.C., District of Columbia, 20006, United States
Pfizer Investigational Site
Longwood, Florida, 32779, United States
Pfizer Investigational Site
Miami, Florida, 33186, United States
Pfizer Investigational Site
Zephyrhills, Florida, 33540, 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
Binghamton, New York, 13901, United States
Pfizer Investigational Site
Brooklyn, New York, 11203, United States
Pfizer Investigational Site
New York, New York, 10022-1009, United States
Pfizer Investigational Site
Cary, North Carolina, 27609, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103, 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
Arlington, Virginia, 22203, United States
Pfizer Investigational Site
Norfolk, Virginia, 23502, United States
Pfizer Investigational Site
Seattle, Washington, 98166, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
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 12, 2008
First Posted
March 19, 2008
Study Start
December 1, 2003
Study Completion
July 1, 2004
Last Updated
February 2, 2021
Record last verified: 2021-01