Clincosm LogoSign in Get a demo

Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis

Sponsor
Chung Shan Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04144101
Collaborator
(none)
40
Enrollment
2
Arms
5
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Comparison of lower dosage etoricoxib (60 mg daily) with aceclofenac (100 mg bid) for their efficacy and safety in the treatment of rheumatoid arthritis (RA).

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

This was a single medical center, parallel-group, randomized controlled trial, which conducted for eight weeks. In this study, 40 patients of RA were randomly assigned to two different treatment groups (etoricoxib and aceclofenac), and 20 patients were enrolled for each group. In addition to baseline data collection, objective assessment tools were used to evaluate for efficacy and safety. The primary endpoint was American College of Rheumatology 20% improvement criteria (ACR20) , secondary endpoints were the ACR 50,70, disease activity score 28 (DAS 28), European League Against Rheumatism (EULAR) response criteria, the number of tender and swollen joints, physician's global assessment, patient's global assessment, pain scores, the short form health survey (SF-36) health Questionnaire and etc. In addition, all adverse reactions were recorded and all the results were analyzed in the intention to treat (ITT) manner.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Comparison of Lower Dosage of Etoricoxib Versus Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis: A Single-center, Parallel-group, Randomized Controlled Pilot Study
Actual Study Start Date :
Mar 1, 2007
Actual Primary Completion Date :
Jul 31, 2007
Actual Study Completion Date :
Jul 31, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Etoricoxib

Etoricoxib 60 mg QD

Drug: Etoricoxib
Etoricoxib 60 mg QD Oral
Other Names:
  • Arcoxia

    		•
    Experimental: Aceclofenac

    Aceclofenac 100 mg BID

    Drug: Aceclofenac
    Aceclofenac 100 mg BID Oral
    Other Names:
  • TONEC

    		•

    Outcome Measures

    Primary Outcome Measures

    1. American College of Rheumatology 20% improvement criteria (ACR20) [week 0, week 8]

      The investigators use ACR20 to compared the difference between the week 8 and week 0

    Secondary Outcome Measures

    1. American College of Rheumatology 50% improvement criteria (ACR50) [week 0, week 8]

      The investigators use ACR50 to compared the difference between the week 8 and week 0

    2. American College of Rheumatology 70% improvement criteria (ACR70) [week 0, week 8]

      The investigators use ACR70 to compared the difference between the week 8 and week 0

    3. Disease activity score 28 (DAS28) [week 0, week 8]

      The investigators use DAS28 to compared the difference between the week 8 and week 0

    4. European League Against Rheumatism (EULAR) response criteria [week 0, week 8]

      The investigators use EULAR responder rate to compared the difference between the week 8 and week 0

    5. The number of tender and swollen joints [week 0, week 8]

      The investigators use the number of tender and swollen joints to compared the difference between the week 8 and week 0

    6. Physician's global assessment (PhGA) [week 0, week 8]

      The investigators use PhGA to compared the difference between the week 8 and week 0

    7. Patient's global assessment (PGA) [week 0, week 8]

      The investigators use PGA to compared the difference between the week 8 and week 0

    8. Visual Analog Scale for pain (VAS) [week 0, week 8]

      The investigators use VAS to compared the difference between the week 8 and week 0

    9. Quality of life by SF-36 [week 0, week 8]

      The investigators use SF-36 to compared the difference between the week 8 and week 0

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis as Rheumatoid Arthritis
    Exclusion Criteria:
      1. Pregnant or breast-feeding women. 2. Chemotherapy or radiation therapy in cancer patients

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Chung Shan Medical University

    Investigators

    • Study Director: Cheng Ching Wei, Ph. D., Chung Shan Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cheng-Chung Wei, Professor, Chung Shan Medical University
    ClinicalTrials.gov Identifier:
    NCT04144101
    Other Study ID Numbers:
    • CS07005
    First Posted:
    Oct 30, 2019
    Last Update Posted:
    Oct 30, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cheng-Chung Wei, Professor, Chung Shan Medical University
    etoricoxib aceclofenac efficacy safety Taiwanese
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Etoricoxib
    Aceclofenac

    Study Results

    No Results Posted as of Oct 30, 2019