Completed
A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients
What is being tested
Pelubiprofen 30 mg
+ Celebrex 200 mg
Drug
Who is being recruted
Arthritis+6
+ Arthritis, Rheumatoid
+ Autoimmune Diseases
From 18 to 80 Years
+6 Eligibility Criteria
How is the trial designed
Supportive Care Study
Phase 3
Interventional
Study Start: October 2010
Summary
Principal SponsorDaewon Pharmaceutical Co., Ltd.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2010
Actual date on which the first participant was enrolled.A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. \& Celebrex Cap. for Comparative Evaluation of Safety \& Efficacy in Rheumatoid Arthritis Patients
Official TitleA Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients
Principal SponsorDaewon Pharmaceutical Co., Ltd.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
ArthritisArthritis, RheumatoidAutoimmune DiseasesConnective Tissue DiseasesImmune System DiseasesJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSkin and Connective Tissue Diseases
Criteria
3 inclusion criteria required to participate
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
3 exclusion criteria prevent from participating
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalPelubiprofen 30 mg, tid
Group II
Active ComparatorCelebrex 200 mg, tid
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers