A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis
NCT ID: NCT01985165
Last Updated: 2013-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
2400 participants
INTERVENTIONAL
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Imrecoxib
0.1g,BID,po
Imrecoxib
Interventions
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Imrecoxib
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with osteoarthritis of the knee according to the American College of Rheumatology
* Functional capacity class of Ⅰ-Ⅲ
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Fengchun Zhang, Professor
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospita
Locations
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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
Taizhou Hospital
Taizhou, Zhejiang, China
BeijingChao-YangHospital
Beijing, , China
China-Japan Friendship Hospital
Beijing, , China
Peking University First Hospital
Beijing, , China
Beijing Hospital of the Ministry of Health
Beijing, , China
Peking Union Medical College Hospita
Beijing, , China
Peking University Third Hospital
Beijing, , China
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, , China
Tianjin First Center Hospital
Tianjin, , China
Countries
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Other Identifiers
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HRARXB00434
Identifier Type: -
Identifier Source: org_study_id