Status:
COMPLETED
Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
Exclusion
- Exclusion criteria:
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT00630929
Start Date
January 1 2003
End Date
February 1 2004
Last Update
February 21 2021
Active Locations (33)
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1
Pfizer Investigational Site
Bad Münder am Deister, Germany, 31848
2
Pfizer Investigational Site
Beckum, Germany, 59269
3
Pfizer Investigational Site
Berlin, Germany, 10435
4
Pfizer Investigational Site
Berlin, Germany, 10559