A Phase 4 interventional study of Celecoxib and Placebo in Osteoarthritis, Knee, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 30 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2021-02-02.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 4, Interventional, and Treatment
To compare the safety and efficacy of celecoxib versus placebo in the treatment of patients with knee osteoarthritis who were unresponsive to treatment with prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 380 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Drug: Celecoxib
Drug: Placebo
200 mg oral capsule once daily for 6 weeks
Matched oral placebo for 6 weeks
Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS)
Time frame: Week 6
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Week 6
Patient's and Physician's Global Assessment of Pain
Time frame: Weeks 2 and 6
The Medical Outcomes Study Sleep Scale
Time frame: Week 6
Adverse events
Time frame: Weeks 0-6
Laboratory tests
Time frame: Week 6
Vital signs
Time frame: Week 6
Physical examination
Time frame: Week 6
Patient's Assessment of Arthritis Pain according to VAS
Time frame: Week 2
Serious adverse events
Time frame: Up to 30 days after last dose
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.