A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis

Phase 4

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Imrecoxib

• 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

Study Timeline

• Study Start: 2013-05
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-07
• Last Update Submitted: 2013-11-07
• Study First Posted: 2013-11-15
• Last Update Posted: 2013-11-15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imrecoxib	Imrecoxib	0.1g,BID,po

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (19)

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

The Second Hospital of Shangdong University; 🇨🇳 Jinan, Shandong, China

Taizhou Hospital; 🇨🇳 Taizhou, Zhejiang, China

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University; 🇨🇳 Chongqing, China

Peking Union Medical College Hospita; 🇨🇳 Beijing, China

BeijingChao-YangHospital; 🇨🇳 Beijing, China

The First People's Hospital of Lianyungang; 🇨🇳 Lianyungang, Jiangsu, China

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China

Cangzhou Central Hospital; 🇨🇳 Cangzhou, Hebei, China

Tianjin First Center Hospital; 🇨🇳 Tianjin, China

Zhejiang Provincial People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Peking University First Hospital; 🇨🇳 Beijing, China

The Second Affiliated Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, China

Beijing Hospital of the Ministry of Health; 🇨🇳 Beijing, China

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

Qianfoshan Hospital Affiliated to Shandong University; 🇨🇳 Jinan, Shandong, China

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China

Peking University Third Hospital; 🇨🇳 Beijing, China