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

August 7, 2013 updated by: Daewon Pharmaceutical Co., Ltd.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pelubiprofen 30 mg
Pelubiprofen 30 mg, tid
Drug: Pelubiprofen 30 mg
ACTIVE_COMPARATOR: Celebrex 200 mg
Celebrex 200 mg, tid
Drug: Celebrex 200 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in '100 mm pain VAS' value from baseline
Time Frame: -14, 0, 14, 28, 42 day
-14, 0, 14, 28, 42 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewon Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

January 30, 2013

First Submitted That Met QC Criteria

January 30, 2013

First Posted (ESTIMATE)

February 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 9, 2013

Last Update Submitted That Met QC Criteria

August 7, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW Plb RA301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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