Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (United States)
A Study of the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Three Times Daily Ibuprofen vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee
1 other identifier
interventional
393
1 country
33
Brief Summary
To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2002
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
October 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 12, 2008
CompletedFirst Posted
Study publicly available on registry
February 22, 2008
CompletedFebruary 21, 2021
February 1, 2021
5 months
February 12, 2008
February 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in patient's assessment of arthritis pain according to visual analogue scale (VAS)
Week 6
Secondary Outcomes (9)
Vital signs
Weeks 2 and 6
Physical examination
Week 6
Laboratory test results
Week 6
Adverse events
Weeks 2 and 6
Change from baseline in patient's and physician's global assessment of pain
Weeks 2 and 6
- +4 more secondary outcomes
Study Arms (3)
Ibuprofen
EXPERIMENTALCelecoxib
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Aged \>= 40 years old
- Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit
- Functional capacity class of I-III
You may not qualify if:
- Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
- Acute joint trauma at index joint within the past 3 months with active symptoms
- Score of \>=20 on PHQ-9 or score of \>=1 on PHQ-9 item i
- Use of mobility assisting device for \<6 weeks or use of walker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Pfizer Investigational Site
Anniston, Alabama, 36207, United States
Pfizer Investigational Site
Phoenix, Arizona, 85051, United States
Pfizer Investigational Site
Anaheim, California, 92804, United States
Pfizer Investigational Site
Long Beach, California, 90806, United States
Pfizer Investigational Site
Paramount, California, 90723, United States
Pfizer Investigational Site
San Diego, California, 92108, United States
Pfizer Investigational Site
DeLand, Florida, 32720, United States
Pfizer Investigational Site
Miami, Florida, 33186, 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
Chicago, Illinois, 60610, United States
Pfizer Investigational Site
Evansville, Indiana, 47712, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89102, United States
Pfizer Investigational Site
Edison, New Jersey, 08817, United States
Pfizer Investigational Site
South Plainfield, New Jersey, 07080, United States
Pfizer Investigational Site
Albuquerque, New Mexico, 87109, 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
Cincinnati, Ohio, 45242, United States
Pfizer Investigational Site
Columbus, Ohio, 43124, United States
Pfizer Investigational Site
Tulsa, Oklahoma, 74136, United States
Pfizer Investigational Site
Altoona, Pennsylvania, 16601, United States
Pfizer Investigational Site
Jenkintown, Pennsylvania, 19046, United States
Pfizer Investigational Site
Newtown, Pennsylvania, 18940, United States
Pfizer Investigational Site
Warwick, Rhode Island, 02886, United States
Pfizer Investigational Site
Charleston, South Carolina, 29407, United States
Pfizer Investigational Site
Greer, South Carolina, 29651, United States
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
Pfizer Investigational Site
Johnson City, Tennessee, 37601, United States
Pfizer Investigational Site
Dallas, Texas, 75235, United States
Pfizer Investigational Site
Layton, Utah, 84041, United States
Pfizer Investigational Site
Danville, Virginia, 24541, 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
February 12, 2008
First Posted
February 22, 2008
Study Start
October 1, 2002
Primary Completion
March 1, 2003
Study Completion
March 1, 2003
Last Updated
February 21, 2021
Record last verified: 2021-02