Knee Osteoarthritis
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Imrecoxib in the treatment of patients with knee osteoarthritis.
Interventions
DRUGImrecoxib
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged form 18 years to 75 years old * Diagnosed with osteoarthritis of the knee according to the American College of Rheumatology * Functional capacity class of Ⅰ-Ⅲ
Exclusion criteria
* Unstable angina * History of myocardial infarction within the last 6 months * Stroke in the 6 months before screening * New York Heart Association class Ⅲ-Ⅳ congestive heart-failure * Systolic blood pressure\>180mmHg,and/or Diastolic blood pressure\>100mmHg * Peptic ulcer * Known contraindications to non-steroidal anti-inflammatory drug（NSAID） * Received aspirin within 3 days of baseline visit * Aspirin dosage\>150mg/d * Known to be Allergic to sulfa and COX-2 inhibitors * Pregnancy or lactation * Glutamic-oxaloacetic transaminase and/or glutamic-pyruvic transaminase\>2 times upper limit of normal * Blood urine nitrogen\>1.5 times upper limit of normal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Patient's Assessment of Arthritis Pain, according to Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)3.0 | Baseline to Week 24 |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Baseline to week 24 |
Countries
China
Outcome results
None listed