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Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rheumatoid Arthritis Patients

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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01781702
Enrollment
120
Registered
2013-02-01
Start date
2010-10-31
Completion date
2011-10-31
Last updated
2013-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celebrex, Pelubiprofen, Rheumatoid Arthritis

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

Interventions

DRUGPelubiprofen 30 mg
DRUGCelebrex 200 mg

Sponsors

Daewon Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Changes in '100 mm pain VAS' value from baseline-14, 0, 14, 28, 42 day

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026