Osteoarthritis, Knee
Conditions
Brief summary
To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis
Interventions
DRUGCelecoxib
200 mg oral capsule once daily for 6 months
DRUGNaproxen
500 mg oral capsule twice daily for 6 months
DRUGPlacebo
Matched oral placebo for 6 months
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
* Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit * Functional Capacity Classification of I-III
Exclusion criteria
* Inflammatory arthritis or gout/pseudo-gout with an acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded) * Received acetaminophen within 24 hours of the baseline visit * Acute joint trauma at index joint within the past 3 months with active symptoms * History of gastrointestinal (GI) perforation, obstruction, or bleeding * Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication * Received corticosteroids or hyaluronic acid within certain timeframe before study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score | Month 6 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Gastrointestinal (GI) Distress Scale from Week 1 | Month 6 |
| Change in WOMAC Subscales from baseline | Month 6 |
| Response in each WOMAC Subscale | Month 6 |
| Change in Medical Outcome Study sleep scale from baseline | Month 6 |
| Laboratory tests | Month 6 |
| Vital signs | Month 6 |
| Response in VAS | Month 6 |
| Change in Patient's and Physician's Global Assessment of Pain from baseline | Month 6 |
| Adverse events | Throughout study |
| Number of health care professional contacts | Throughout study |
| Patient's and Physician's Satisfaction with Current Arthritis Therapy | Month 6 |
| Change in WOMAC Total Score from baseline | Month 6 |
| Change in GI Distress Scale from time of discontinuation of study drug | Month 6 |
| Receipt of prescription or over-the-counter gastroprotective agents or pain medications (off study drug) | Throughout study |
| Number of hospitalizations, emergency room visits, and procedures | Throughout study |
| Change in Work Limitation Questionnaire scale scores from baseline | Month 6 |
| Physical examination | Month 6 |
| Change in visual analog scale (VAS) from baseline | Month 6 |
Countries
United States
Outcome results
None listed