Clinical trial NCT01985165: A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis
Official title: A Multicenter，Open-label Phase Ⅳ Trial of Imrecoxib in Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Knee Osteoarthritis
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-11-15
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Imrecoxib in the treatment of patients with knee osteoarthritis.


Eligibility 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

Primary outcomes:
measure: Change from baseline in Patient's Assessment of Arthritis Pain, according to Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)3.0
timeFrame: Baseline to Week 24
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Baseline to week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: Hebei
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Lianyungang
country: China
facility: The First People's Hospital of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Qianfoshan Hospital Affiliated to Shandong University
state: Shandong
city: Jinan
country: China
facility: The Second Hospital of Shangdong University
state: Shandong
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital
state: Zhejiang
city: Beijing
country: China
facility: BeijingChao-YangHospital
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Hospital of the Ministry of Health
city: Beijing
country: China
facility: Peking Union Medical College Hospita
city: Beijing
country: China
facility: Peking University Third Hospital
city: Chongqing
country: China
facility: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
city: Tianjin
country: China
facility: Tianjin First Center Hospital
Study officials:
affiliation: Peking Union Medical College Hospita
name: Fengchun Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References: