Knee osteoarthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age greater than or equal to 18 years old; 2) Diagnosed with significant osteoarthritis or rheumatoid arthritis for at least three months; 3) continuous NSAIDs therapy (>= 6 months).
Exclusion criteria
Exclusion criteria: 1) Accompanied by ischemic heart disease, heart failure, peripheral arterial disease, cerebrovascular disease, gastrointestinal bleeding or active gastroduodenal ulcer and inflammatory bowel disease within 90 days before screening; 2) simultaneous use of antiplatelet or anticoagulants; 3) kidney, hepatic or coagulation dysfunction; 4) with malignant tumor (unless surgically resected and no recurrence within 5 years); 5) history of gastric or duodenal surgery (non-gastric suture); 6) Pregnant or lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whether upper and/or lower GI events have occurred;Change from baseline in hematocrit;Whether there is a clinically significant decrease in hematocrit and/or hemoglobin from baseline;? Liver AEs in glutamyl transferase (GGT), aspartate aminotransferase (AST), or alanine aminotransferase (ALT) at 3 times the upper limit of normal;Change from baseline in C-reactive protein; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in hemoglobin; | — |
Countries
China
Contacts
Shanghai Sixth People's Hospital