A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis
A Multicenter，Open-label Phase Ⅳ Trial of Imrecoxib in Treatment of Knee Osteoarthritis
1 other identifier
interventional
2,400
1 country
19
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Imrecoxib in the treatment of patients with knee osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 knee-osteoarthritis
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
November 15, 2013
CompletedNovember 15, 2013
November 1, 2013
6 months
November 1, 2013
November 7, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
Imrecoxib
EXPERIMENTAL0.1g,BID,po
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
The Second Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Tongji Hospital
Wuhan, Hubei, 430030, China
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222002, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Qianfoshan Hospital Affiliated to Shandong University
Jinan, Shandong, 250014, 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, 100020, China
China-Japan Friendship Hospital
Beijing, 100029, China
Peking University First Hospital
Beijing, 100034, China
Beijing Hospital of the Ministry of Health
Beijing, 100730, 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, 400042, China
Tianjin First Center Hospital
Tianjin, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fengchun Zhang, Professor
Peking Union Medical College Hospita
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2013
First Posted
November 15, 2013
Study Start
May 1, 2013
Primary Completion
November 1, 2013
Last Updated
November 15, 2013
Record last verified: 2013-11