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A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01985165
Recruitment Status : Unknown
Verified November 2013 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : November 15, 2013
Last Update Posted : November 15, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Imrecoxib Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter,Open-label Phase Ⅳ Trial of Imrecoxib in Treatment of Knee Osteoarthritis
Study Start Date : May 2013
Estimated Primary Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Imrecoxib
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Drug: Imrecoxib



Primary Outcome Measures :
  1. Change from baseline in Patient's Assessment of Arthritis Pain, according to Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)3.0 [ Time Frame: Baseline to Week 24 ]
  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Baseline to week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985165


Locations
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China, Guangdong
The Second Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
China, Hebei
Cangzhou Central Hospital
Cangzhou, Hebei, China
China, Hubei
Tongji Hospital
Wuhan, Hubei, China, 430030
China, Jiangsu
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China, 222002
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
China, Liaoning
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
China, Shandong
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Qianfoshan Hospital Affiliated to Shandong University
Jinan, Shandong, China, 250014
The Second Hospital of Shangdong University
Jinan, Shandong, China
China, Zhejiang
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital
Taizhou, Zhejiang, China
China
BeijingChao-YangHospital
Beijing, China, 100020
China-Japan Friendship Hospital
Beijing, China, 100029
Peking University First Hospital
Beijing, China, 100034
Beijing Hospital of the Ministry of Health
Beijing, China, 100730
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, 400042
Tianjin First Center Hospital
Tianjin, China
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Fengchun Zhang, Professor Peking Union Medical College Hospita

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT01985165     History of Changes
Other Study ID Numbers: HRARXB00434
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases