Osteoarthritis, Knee
Conditions
Brief summary
To compare the efficacy and safety of celecoxib versus placebo for the treatment of knee osteoarthritis (OA) in patients who were unresponsive to prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen
Interventions
DRUGCelecoxib
200 mg oral capsule once daily with morning meal for 6 weeks
OTHERPlacebo
Matched oral placebo 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: * Diagnosed, active, and symptomatic OA of the knee in a flare state with a functional capacity class of I-III at baseline visit * Failed adequate trials of both naproxen and ibuprofen (prescription strength) within the past 5 years due to lack of efficacy, tolerability, or both; duration of prescription strength ibuprofen and naproxen must have been a minimum of 2 weeks for each drug at the respective recommended doses if failure was due to lack of efficacy, and for any duration if failure was due to lack of tolerability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS) | Week 6 |
Secondary
| Measure | Time frame |
|---|---|
| The Western Ontario and McMaster Universities Osteoarthritis Index | Week 6 |
| Patient's and Physician's Global Assessment of Arthritis | Weeks 2 and 6 |
| The Medical Outcomes Study Sleep Scale | Week 6 |
| Adverse events | Weeks 0-6 |
| Patient's Assessment of Arthritis Pain, according to VAS | Week 2 |
| Vital signs | Week 6 |
| Physical examination | Week 6 |
| Serious adverse events | Up to 30 days after last dose |
| Laboratory tests | Week 6 |
Countries
United States
Outcome results
None listed