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

Phase 3

Completed

• Conditions: Pelubiprofen; Celebrex; Rheumatoid Arthritis
• Interventions: Drug: Pelubiprofen 30 mg; Drug: Celebrex 200 mg

• Registration Number: NCT01781702
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

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 available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Study First Submitted: 2013-01-30
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-02-01
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-07
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pelubiprofen 30 mg	Pelubiprofen 30 mg	Pelubiprofen 30 mg, tid
Celebrex 200 mg	Celebrex 200 mg	Celebrex 200 mg, tid

Primary Outcome Measures

Name	Time	Method
Changes in '100 mm pain VAS' value from baseline	-14, 0, 14, 28, 42 day