MedDataX Logo

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

NCT ID: NCT01781702

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pelubiprofen Celebrex Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pelubiprofen 30 mg

Pelubiprofen 30 mg, tid

Group Type EXPERIMENTAL

Pelubiprofen 30 mg

Intervention Type DRUG

Celebrex 200 mg

Celebrex 200 mg, tid

Group Type ACTIVE_COMPARATOR

Celebrex 200 mg

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pelubiprofen 30 mg

Intervention Type DRUG

Celebrex 200 mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Daewon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

References

Explore related publications, articles, or registry entries linked to this study.

Choi IA, Baek HJ, Cho CS, Lee YA, Chung WT, Park YE, Lee YJ, Park YB, Lee J, Lee SS, Yoo WH, Song JS, Kang SW, Kim HA, Song YW. Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, double-blind, phase III, non-inferiority clinical trial. BMC Musculoskelet Disord. 2014 Nov 18;15:375. doi: 10.1186/1471-2474-15-375.

Reference Type DERIVED
PMID: 25403311 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DW Plb RA301

Identifier Type: -

Identifier Source: org_study_id