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

Daewon Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Celebrex; Pelubiprofen; Rheumatoid Arthritis

Treatments: Drug: Celebrex 200 mg; Drug: Pelubiprofen 30 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01781702

DW Plb RA301

Details and patient eligibility

About

A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Pelubiprofen 30 mg

Experimental group

Description:

Pelubiprofen 30 mg, tid

Treatment:

Drug: Pelubiprofen 30 mg

Celebrex 200 mg

Active Comparator group

Description:

Celebrex 200 mg, tid

Treatment:

Drug: Celebrex 200 mg