Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rheumatoid Arthritis Patients
Primary Purpose
Pelubiprofen, Celebrex, Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pelubiprofen 30 mg
Celebrex 200 mg
Sponsored by
About this trial
This is an interventional supportive care trial for Pelubiprofen
Eligibility Criteria
Inclusion Criteria:
- Adult males/Females aged 18~80 years
- Patient who are taking NSAIDs for the treatment of rheumatoid arthritis
- Patients who belong to ACR functional class 1, 2, 3
Exclusion Criteria:
- Patients who belong to ACR functional class 4
- Patients who are hypersensitive to clinical trial medicines or excipient
- Patients who have experience of Cerebrovascular bleeding, bleeding disorder
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pelubiprofen 30 mg
Celebrex 200 mg
Arm Description
Pelubiprofen 30 mg, tid
Celebrex 200 mg, tid
Outcomes
Primary Outcome Measures
Changes in '100 mm pain VAS' value from baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT01781702
First Posted
January 30, 2013
Last Updated
August 7, 2013
Sponsor
Daewon Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01781702
Brief Title
Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rheumatoid Arthritis Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewon Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelubiprofen, Celebrex, Rheumatoid Arthritis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pelubiprofen 30 mg
Arm Type
Experimental
Arm Description
Pelubiprofen 30 mg, tid
Arm Title
Celebrex 200 mg
Arm Type
Active Comparator
Arm Description
Celebrex 200 mg, tid
Intervention Type
Drug
Intervention Name(s)
Pelubiprofen 30 mg
Intervention Type
Drug
Intervention Name(s)
Celebrex 200 mg
Primary Outcome Measure Information:
Title
Changes in '100 mm pain VAS' value from baseline
Time Frame
-14, 0, 14, 28, 42 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult males/Females aged 18~80 years
Patient who are taking NSAIDs for the treatment of rheumatoid arthritis
Patients who belong to ACR functional class 1, 2, 3
Exclusion Criteria:
Patients who belong to ACR functional class 4
Patients who are hypersensitive to clinical trial medicines or excipient
Patients who have experience of Cerebrovascular bleeding, bleeding disorder
12. IPD Sharing Statement
Citations:
PubMed Identifier
25403311
Citation
Choi IA, Baek HJ, Cho CS, Lee YA, Chung WT, Park YE, Lee YJ, Park YB, Lee J, Lee SS, Yoo WH, Song JS, Kang SW, Kim HA, Song YW. Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, double-blind, phase III, non-inferiority clinical trial. BMC Musculoskelet Disord. 2014 Nov 18;15:375. doi: 10.1186/1471-2474-15-375.
Results Reference
derived
Learn more about this trial
Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rheumatoid Arthritis Patients
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