Skip to main content
OpenTrials
Completed

NCT Number: NCT04144101

Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis as Rheumatoid Arthritis

Exclusion criteria

  • 1. Pregnant or breast-feeding women. 2. Chemotherapy or radiation therapy in cancer patients

Treatment and study plan

Etoricoxib

Drug

Etoricoxib 60 mg QD Oral

Other names: Arcoxia

Aceclofenac

Drug

Aceclofenac 100 mg BID Oral

Other names: TONEC

Primary outcomes

  1. American College of Rheumatology 20% improvement criteria (ACR20)

    Time frame: week 0, week 8

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

Secondary outcomes

  1. American College of Rheumatology 50% improvement criteria (ACR50)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: week 0, week 8

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

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Oct 30, 2019
Registry last updated
Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.