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A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis

Phase 4
Conditions
Knee Osteoarthritis
Interventions
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
ImrecoxibImrecoxib0.1g,BID,po
Primary Outcome Measures
NameTimeMethod
Change from baseline in Patient's Assessment of Arthritis Pain, according to Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)3.0Baseline to Week 24
Number of Participants with Adverse Events as a Measure of Safety and TolerabilityBaseline to week 24
Secondary Outcome Measures
NameTimeMethod

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

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