Osteoarthritis, Knee
Conditions
Brief summary
To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.
Interventions
DRUGIbuprofen
800 mg oral tablet 3 times daily with meals for 6 weeks
DRUGPlacebo
Matched placebo orally for 6 weeks
DRUGCelecoxib
200 mg oral capsule once daily with morning meal for 6 weeks
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in patient's assessment of arthritis pain according to visual analogue scale | Week 6 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| The Patient Health Questionnaire (PHQ-9) | Week 6 |
| Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores | Days 1-7 |
| Adverse events | Weeks 2 and 6 |
| Laboratory test results | Week 6 |
| Vital signs | Weeks 2 and 6 |
| Physical examination | Week 6 |
| Measurement of upper gastrointestinal tolerability | Weeks 2 and 6 |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed