A Phase 2 interventional study of ARRY-371797, p38 inhibitor; oral and Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral in Osteoarthritis of the Knee, sponsored by Pfizer. Completed at 13 sites in United States. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-10-14.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
This is a Phase 2 study, involving a 4-week treatment period, designed to test the ability of investigational study drug ARRY-371797 to reduce pain in patients with moderate to severe pain due to osteoarthritis (OA) of the knee, and to further evaluate the drug's safety. Approximately 150 patients from the US will be enrolled in this study.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 157 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Drug: ARRY-371797, p38 inhibitor; oral
Drug: Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral
Drug: Placebo; oral
multiple dose, single schedule
multiple dose, single schedule
matching placebo
Assess the efficacy of the study drug (versus placebo) in terms of change from baseline to week 4 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score (index knee).
Time frame: 4 weeks
Assess the efficacy of the study drug (versus placebo) in terms of change from baseline to week 4 in the WOMAC stiffness and physical function subscale scores (index knee).
Time frame: 4 weeks
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.
Time frame: 5 weeks
Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.
Time frame: 4 weeks
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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