Status and phase
Conditions
Treatments
About
This Phase IV clinical study is to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Rheumatoid Arthritis Patients
Full description
Thisi is a multi-center, double-blind, active-controlled, randomized, parallel-group clinical trial to compare the efficacy and safety of CELBESTA® and CELEBREX® in patients with rheumatoid arthritis. The subject will receive two tablets twice daily for 6 weeks.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
History of angina pectoris or congestive heart failure at rest or minimum activity
History of myocardial infarction or artherosclerosis
Patients who had a coronary angioplaty or coronary artery bypass graft within 1 year
History of stroke, transient ischemic attack or hepatitis within 2 years
Patients who have uncontrolled hypertension at screening
Patients who take the medicines that might effect the test results by study investigators or might cause a excessive risk to the patients
History of a malignant tumor (except for the patients whose tumor was removed and there's no recurrence within 5 years)
Patients who have gastrointestinal bleeding or peptic ulcer (except scar) within 30 days
History of a gastroesophageal surgery such as antigastric-secretion surgery or esophagogastrectomy (except a simple perforator surgery)
Patients who have severe disability in GI, Kidney, Liver and Blood
Pregnant women, Lactating women and Women of child-bering potential who are not using adequate means of contraception
History of allergy to COX-2 inhibitors or sulphonamides or other NSAIDs
Any condition that, in the view of the investigator, would interfere with study participation
Primary purpose
Allocation
Interventional model
Masking
119 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal