A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

A Multicenter，Open-label Phase Ⅳ Trial of Imrecoxib in Treatment of Knee Osteoarthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01985165
• Other study ID #: HRARXB00434
• Status: Active, not recruiting
• Phase: Phase 4
• First received: November 1, 2013
• Last updated: November 7, 2013
• Start date: May 2013

Study information

• Verified date: November 2013
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2400
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 ?-?

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 ?-? 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Imrecoxib

Locations

Country	Name	City	State
China	Beijing Hospital of the Ministry of Health	Beijing
China	BeijingChao-YangHospital	Beijing
China	China-Japan Friendship Hospital	Beijing
China	Peking Union Medical College Hospita	Beijing
China	Peking University First Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	Cangzhou Central Hospital	Cangzhou	Hebei
China	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Chongqing
China	The Second Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Qianfoshan Hospital Affiliated to Shandong University	Jinan	Shandong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	The Second Hospital of Shangdong University	Jinan	Shandong
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	Taizhou Hospital	Taizhou	Zhejiang
China	Tianjin First Center Hospital	Tianjin
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Baseline to week 24	Yes