Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)
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
388
3 countries
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 Jan 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
January 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 28, 2008
CompletedFirst Posted
Study publicly available on registry
March 7, 2008
CompletedFebruary 21, 2021
February 1, 2021
February 28, 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
Week 6
Secondary Outcomes (11)
Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores
Days 1-7
Change from baseline in patient's assessment of arthritis pain according to visual analogue scale
Week 2
Change from baseline in patient and physician global assessments of arthritis
Weeks 2 and 6
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index
Week 6
The Pain Satisfaction Scale
Week 6
- +6 more secondary outcomes
Study Arms (3)
A
ACTIVE COMPARATORC
PLACEBO COMPARATORB
EXPERIMENTALInterventions
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
Bad Münder am Deister, 31848, Germany
Pfizer Investigational Site
Beckum, 59269, Germany
Pfizer Investigational Site
Berlin, 10435, Germany
Pfizer Investigational Site
Berlin, 10559, Germany
Pfizer Investigational Site
Berlin, 12687, Germany
Pfizer Investigational Site
Berlin, 13125, Germany
Pfizer Investigational Site
Ostseebad Damp, 24351, Germany
Pfizer Investigational Site
Schwerin, 19057, Germany
Pfizer Investigational Site
Stade, 21680, Germany
Pfizer Investigational Site
Tostedt, 21255, Germany
Pfizer Investigational Site
Weener, 26826, Germany
Pfizer Investigational Site
Barcelona, 08029, Spain
Pfizer Investigational Site
Barcelona, 08036, Spain
Pfizer Investigational Site
Cadiz, 11009, Spain
Pfizer Investigational Site
Guadalajara, 19002, Spain
Pfizer Investigational Site
Madrid, 28035, Spain
Pfizer Investigational Site
Madrid, 28040, Spain
Pfizer Investigational Site
Madrid, 28046, Spain
Pfizer Investigational Site
Oviedo, 33006, Spain
Pfizer Investigational Site
Seville, 41014, Spain
Pfizer Investigational Site
Valencia, 46009, Spain
Pfizer Investigational Site
Chelmsly WOOD, Birmingham, B37 7TR, United Kingdom
Pfizer Investigational Site
Truro, Cornwall, TR1 3LJ, United Kingdom
Pfizer Investigational Site
Chorley, Lancs, PR7 1NY, United Kingdom
Pfizer Investigational Site
Liverpool, Lancs, L1 9AD, United Kingdom
Pfizer Investigational Site
Cannock, Mid Staffordshire, WS11 2XY, United Kingdom
Pfizer Investigational Site
Addlestone, Surrey, KT15 2BH, United Kingdom
Pfizer Investigational Site
Huddersfield, HD3 3EA, United Kingdom
Pfizer Investigational Site
London, NW3 2PF, United Kingdom
Pfizer Investigational Site
London, SE5 9RS, United Kingdom
Pfizer Investigational Site
Manchester, M41 5SL, United Kingdom
Pfizer Investigational Site
Newcastle upon Tyne, NE7 7DN, United Kingdom
Pfizer Investigational Site
Wigan, WN6 9EW, United Kingdom
Related Publications (1)
Gordo AC, Walker C, Armada B, Zhou D. Efficacy of celecoxib versus ibuprofen for the treatment of patients with osteoarthritis of the knee: A randomized double-blind, non-inferiority trial. J Int Med Res. 2017 Feb;45(1):59-74. doi: 10.1177/0300060516673707. Epub 2017 Jan 12.
PMID: 28222627DERIVED
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 28, 2008
First Posted
March 7, 2008
Study Start
January 1, 2003
Study Completion
February 1, 2004
Last Updated
February 21, 2021
Record last verified: 2021-02