Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)
NCT ID: NCT00630929
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
388 participants
INTERVENTIONAL
2003-01-31
2004-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
Ibuprofen
800 mg oral tablet 3 times daily with meals for 6 weeks
C
Placebo
Matched placebo orally for 6 weeks
B
Celecoxib
200 mg oral capsule once daily with morning meal for 6 weeks
Interventions
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Ibuprofen
800 mg oral tablet 3 times daily with meals for 6 weeks
Placebo
Matched placebo orally for 6 weeks
Celecoxib
200 mg oral capsule once daily with morning meal for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
40 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Bad Münder am Deister, , Germany
Pfizer Investigational Site
Beckum, , Germany
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Ostseebad Damp, , Germany
Pfizer Investigational Site
Schwerin, , Germany
Pfizer Investigational Site
Stade, , Germany
Pfizer Investigational Site
Tostedt, , Germany
Pfizer Investigational Site
Weener, , Germany
Pfizer Investigational Site
Barcelona, , Spain
Pfizer Investigational Site
Barcelona, , Spain
Pfizer Investigational Site
Cadiz, , Spain
Pfizer Investigational Site
Guadalajara, , Spain
Pfizer Investigational Site
Madrid, , Spain
Pfizer Investigational Site
Madrid, , Spain
Pfizer Investigational Site
Madrid, , Spain
Pfizer Investigational Site
Oviedo, , Spain
Pfizer Investigational Site
Seville, , Spain
Pfizer Investigational Site
Valencia, , Spain
Pfizer Investigational Site
Chelmsly WOOD, Birmingham, United Kingdom
Pfizer Investigational Site
Truro, Cornwall, United Kingdom
Pfizer Investigational Site
Chorley, Lancs, United Kingdom
Pfizer Investigational Site
Liverpool, Lancs, United Kingdom
Pfizer Investigational Site
Cannock, Mid Staffordshire, United Kingdom
Pfizer Investigational Site
Addlestone, Surrey, United Kingdom
Pfizer Investigational Site
Huddersfield, , United Kingdom
Pfizer Investigational Site
London, , United Kingdom
Pfizer Investigational Site
London, , United Kingdom
Pfizer Investigational Site
Manchester, , United Kingdom
Pfizer Investigational Site
Newcastle upon Tyne, , United Kingdom
Pfizer Investigational Site
Wigan, , United Kingdom
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3191062
Identifier Type: -
Identifier Source: org_study_id
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