A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis

Hengrui Medicine

Status and phase: Unknown; Phase 4

Conditions: Knee Osteoarthritis

Treatments: Drug: Imrecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01985165

HRARXB00434

Details and patient eligibility

About

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

Enrollment: 2,400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,400 participants in 1 patient group

Imrecoxib

Experimental group

Description:

0.1g,BID,po

Treatment:

Drug: Imrecoxib