Study to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid Arthritis
NCT ID: NCT02780323
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
119 participants
INTERVENTIONAL
2015-11-02
2017-12-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CELBESTA® and CELEBREX® placebo
CELBESTA® and CELEBREX® placebo is administered twice daily for 6 weeks
CELBESTA®
1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks
CELEBREX® placebo
1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks
CELEBREX®
CELEBREX® and CELBESTA® placebo is administered twice daily for 6 weeks
CELEBREX®
1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks
CELBESTA® placebo
1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks
Interventions
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CELBESTA®
1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks
CELEBREX®
1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks
CELEBREX® placebo
1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks
CELBESTA® placebo
1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects who are diagnosed as established rheumatoid arthritis at screening visit and before
* Pain greater than 40/100mm-VAS(Visual Analgue Scale) after wash-out period
* Patients who are taking oral corticosteroids without dosage change (within a range of prednisolone 10mg a day) at least 4weeks and more than 1 DMARDs at least 3 months from screening test
* Patients willing and able to provide signed informed consent after the nature of the study has been explained
Exclusion Criteria
* 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
* Intra-articular corticosteroid injection within 4 weeks from screening
* biological DMARDs such as infliximab, adlimumab, entanercept, anakinara or abatacept wihin 6 months from randomization
* biological DMARDs such as rituximab within 1 year from randomization
* 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
19 Years
ALL
No
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Seung-jae Hong, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Kyung Hee University Hospital
Sungsoo Kim, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Gangneung Asan Hospital
Sangil Lee, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Gyeongsang National Hospital
Changnam Son, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Keimyung University Dongsan Medical Center
Yeong Ho Seo, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Korea University
Geun-Tae Kim, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Kosin University Gospel Hospital
Jin-Wuk Hur, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul Eulji Hospital
Hyun-Sook Kim, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Soonchunhyang University Hospital
Myeong Soo Lee, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Wonkwang University Hospital
Yun Sung Kim, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Chosun University Hospital
Locations
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Kyung Hee University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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CELB_RA_IV
Identifier Type: -
Identifier Source: org_study_id
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