A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis
- Registration Number
- NCT01985165
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Imrecoxib in the treatment of patients with knee osteoarthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2400
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Imrecoxib Imrecoxib 0.1g,BID,po
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
The Second Affiliated Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Cangzhou Central Hospital
🇨🇳Cangzhou, Hebei, China
Tongji Hospital
🇨🇳Wuhan, Hubei, China
The First People's Hospital of Lianyungang
🇨🇳Lianyungang, Jiangsu, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Qianfoshan Hospital Affiliated to Shandong University
🇨🇳Jinan, Shandong, China
The Second Hospital of Shangdong University
🇨🇳Jinan, Shandong, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Scroll for more (9 remaining)The Second Affiliated Hospital of Sun Yat-Sen University🇨🇳Guangzhou, Guangdong, China