Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients
Verified date | August 2013 |
Source | Daewon Pharmaceutical Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients
Status | Completed |
Enrollment | 120 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Adult males/Females aged 18~80 years 2. Patient who are taking NSAIDs for the treatment of rheumatoid arthritis 3. Patients who belong to ACR functional class 1, 2, 3 Exclusion Criteria: 1. Patients who belong to ACR functional class 4 2. Patients who are hypersensitive to clinical trial medicines or excipient 3. Patients who have experience of Cerebrovascular bleeding, bleeding disorder |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Daewon Pharmaceutical Co., Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in '100 mm pain VAS' value from baseline | -14, 0, 14, 28, 42 day |
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