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

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Key information

Conditions

Pelubiprofen Arthritis Arthritis, Rheumatoid Autoimmune Diseases Celebrex Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelubiprofen 30 mg

Drug

Celebrex 200 mg

Drug

Primary outcomes

Changes in '100 mm pain VAS' value from baseline

Time frame: -14, 0, 14, 28, 42 day

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Feb 1, 2013
Registry last updated: Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed