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

Information source: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pelubiprofen; Celebrex; Rheumatoid Arthritis

Intervention: Pelubiprofen 30 mg (Drug); Celebrex 200 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Daewon Pharmaceutical Co., Ltd.

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Primary outcome: Changes in '100 mm pain VAS' value from baseline

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: October 2010
Last updated: August 7, 2013

Page last updated: August 20, 2015

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