Efficacy and Safety of Celecoxib Versus Placebo in the Treatment of Patients With Osteoarthritis of the Knee 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
380
1 country
30
Brief Summary
To compare the safety and efficacy of celecoxib versus placebo in the treatment of patients with knee osteoarthritis who were unresponsive to treatment with 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
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 17, 2008
CompletedFirst Posted
Study publicly available on registry
March 21, 2008
CompletedFebruary 2, 2021
January 1, 2021
March 17, 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)
Western Ontario and McMaster Universities Osteoarthritis Index
Week 6
Patient's and Physician's Global Assessment of Pain
Weeks 2 and 6
The Medical Outcomes Study Sleep Scale
Week 6
Adverse events
Weeks 0-6
Laboratory tests
Week 6
- +4 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- OA of the knee in flare state at baseline visit and functional capacity class of I-III
- 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 baseline visit
- Use of 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
- Recieved corticosteroids or hyaluronic acid within certain timeframe before study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Pfizer Investigational Site
Phoenix, Arizona, 85051, United States
Pfizer Investigational Site
Tucson, Arizona, 85712, United States
Pfizer Investigational Site
Long Beach, California, 90806, United States
Pfizer Investigational Site
Paramount, California, 90723, United States
Pfizer Investigational Site
Tustin, California, 92780, United States
Pfizer Investigational Site
Colorado Springs, Colorado, 80904, United States
Pfizer Investigational Site
Wheat Ridge, Colorado, 80033, United States
Pfizer Investigational Site
DeLand, Florida, 32720, United States
Pfizer Investigational Site
Naples, Florida, 34102, United States
Pfizer Investigational Site
Pembroke Pines, Florida, 33024, United States
Pfizer Investigational Site
St. Petersburg, Florida, 33710, United States
Pfizer Investigational Site
Woodstock, Georgia, 30189, United States
Pfizer Investigational Site
Overland Park, Kansas, 66215, United States
Pfizer Investigational Site
New Orleans, Louisiana, 70119, United States
Pfizer Investigational Site
Baltimore, Maryland, 21239, United States
Pfizer Investigational Site
Flowood, Mississippi, 39232, United States
Pfizer Investigational Site
Chesterfield, Missouri, 63017, United States
Pfizer Investigational Site
Reno, Nevada, 89502, United States
Pfizer Investigational Site
Albuquerque, New Mexico, 87109, United States
Pfizer Investigational Site
Mason, Ohio, 45040, United States
Pfizer Investigational Site
Beaver, Pennsylvania, 15009, United States
Pfizer Investigational Site
Camp Hill, Pennsylvania, 17011, United States
Pfizer Investigational Site
Jenkintown, Pennsylvania, 19046, United States
Pfizer Investigational Site
Greensboro, South Carolina, 27401, United States
Pfizer Investigational Site
Johnson City, Tennessee, 37601, United States
Pfizer Investigational Site
Murfreesboro, Tennessee, 37130, United States
Pfizer Investigational Site
Nashville, Tennessee, 37203, United States
Pfizer Investigational Site
Austin, Texas, 78705, United States
Pfizer Investigational Site
San Antonio, Texas, 78217, United States
Pfizer Investigational Site
Seattle, Washington, 98133, 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 17, 2008
First Posted
March 21, 2008
Study Start
December 1, 2003
Study Completion
September 1, 2004
Last Updated
February 2, 2021
Record last verified: 2021-01