Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rheumatoid Arthritis Patients
Overview[ - collapse ][ - ]
Purpose | A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients |
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Condition | Pelubiprofen Celebrex Rheumatoid Arthritis |
Intervention | Drug: Pelubiprofen 30 mg Drug: Celebrex 200 mg |
Phase | Phase 3 |
Sponsor | Daewon Pharmaceutical Co., Ltd. |
Responsible Party | Daewon Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier | NCT01781702 |
First Received | January 30, 2013 |
Last Updated | August 7, 2013 |
Last verified | August 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | January 30, 2013 |
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Last Updated Date | August 7, 2013 |
Start Date | October 2010 |
Estimated Primary Completion Date | October 2011 |
Current Primary Outcome Measures | Changes in '100 mm pain VAS' value from baseline [Time Frame: -14, 0, 14, 28, 42 day] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rheumatoid Arthritis Patients |
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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 |
Brief Summary | A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care |
Condition |
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Intervention | Drug: Pelubiprofen 30 mg Drug: Celebrex 200 mg |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 120 |
Estimated Completion Date | October 2011 |
Estimated Primary Completion Date | October 2011 |
Eligibility Criteria | 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01781702 |
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Other Study ID Numbers | DW Plb RA301 |
Has Data Monitoring Committee | Yes |
Information Provided By | Daewon Pharmaceutical Co., Ltd. |
Study Sponsor | Daewon Pharmaceutical Co., Ltd. |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | August 2013 |