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

Primary Purpose

Pelubiprofen, Celebrex, Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pelubiprofen 30 mg
Celebrex 200 mg
Sponsored by
Daewon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pelubiprofen

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Pelubiprofen 30 mg

    Celebrex 200 mg

    Arm Description

    Pelubiprofen 30 mg, tid

    Celebrex 200 mg, tid

    Outcomes

    Primary Outcome Measures

    Changes in '100 mm pain VAS' value from baseline

    Secondary Outcome Measures

    Full Information

    First Posted
    January 30, 2013
    Last Updated
    August 7, 2013
    Sponsor
    Daewon Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01781702
    Brief Title
    Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rheumatoid Arthritis Patients
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2010 (undefined)
    Primary Completion Date
    October 2011 (Actual)
    Study Completion Date
    October 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Daewon Pharmaceutical Co., Ltd.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelubiprofen, Celebrex, Rheumatoid Arthritis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pelubiprofen 30 mg
    Arm Type
    Experimental
    Arm Description
    Pelubiprofen 30 mg, tid
    Arm Title
    Celebrex 200 mg
    Arm Type
    Active Comparator
    Arm Description
    Celebrex 200 mg, tid
    Intervention Type
    Drug
    Intervention Name(s)
    Pelubiprofen 30 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Celebrex 200 mg
    Primary Outcome Measure Information:
    Title
    Changes in '100 mm pain VAS' value from baseline
    Time Frame
    -14, 0, 14, 28, 42 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25403311
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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