This trial is active, not recruiting.

Condition knee osteoarthritis
Treatment imrecoxib
Phase phase 4
Sponsor Jiangsu HengRui Medicine Co., Ltd.
Start date May 2013
End date November 2013
Trial size 2400 participants
Trial identifier NCT01985165, HRARXB00434


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Change from baseline in Patient's Assessment of Arthritis Pain, according to Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)3.0
time frame: Baseline to Week 24
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: Baseline to week 24

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title A Multicenter,Open-label Phase Ⅳ Trial of Imrecoxib in Treatment of Knee Osteoarthritis
Principal investigator Fengchun Zhang, Professor
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd..