osteoarthritis
Conditions
Interventions
single arm:Imrecoxib
Sponsors
Nanjing Drum Tower Hospital Affiliated to Medical College of Nanjing University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Patient is willing to obey the Study Protocol and able to read, understand and complete study questionnaires, including questions requiring a visual analog scale (VAS) response. 2.Aged 18-65 years; 3.Clinical diagnosis of osteoarthritis of the knee according to ACR criteria , Patient is of American Rheumatism Association (ARA) functional Class I, II, or III. 4. The investigator believes that subjects need to be treated with NSAIDs and expect to be treated with NSAIDs for at least eight weeks.
Exclusion criteria
Exclusion criteria: 1.Patients that are pregnant or breast-feeding, or expecting to conceive within the projected duration of the study; 2.Patients with a history of active gastrointestinal ulcer/bleeding disorders, or recurrent ulcer/ bleeding disorders; 3.Patients with a history of gastrointestinal bleeding or perforation associated with NSAIDs; 4.Patients with a history of asthma, urticaria or allergic reaction associated with NSAIDs; 5.Severe heart failure; 6.Analgesic patients undergoing coronary artery bypass surgery; 7.Patient has hepatic insufficiency with AST or ALT > 2 times the upper limit of normal value, or BUN > 1.5 times the upper limit of normal value; 8.Patients using non-study NSAID or cyclooxygenase 2 (COX-2) specific inhibitor within 1 week of the screening period 9.Patient has an estimated glomerular filtration rate is less than or equal to 30 ml/min; 10.The investigator believes that it is not suitable for patients participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS;WOMAC;plasma concentration of Imrecoxib;CYP2C9, CYP2D6, CYP3A4; | — |
Countries
China
Contacts
Public ContactQing Jiang
Nanjing Drum Tower Hospital Affiliated to Medical College of Nanjing University
Outcome results
None listed