A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of Imrecoxib in the treatment of patients with knee osteoarthritis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

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