Back to resultsEtoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Etoricoxib
Aceclofenac
Sponsored by
About this trial
This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring etoricoxib aceclofenac efficacy safety Taiwanese
Eligibility Criteria
Inclusion Criteria:
- Diagnosis as Rheumatoid Arthritis
Exclusion Criteria:
- 1. Pregnant or breast-feeding women. 2. Chemotherapy or radiation therapy in cancer patients
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Etoricoxib
Aceclofenac
Arm Description
Etoricoxib 60 mg QD
Aceclofenac 100 mg BID
Outcomes
Primary Outcome Measures
American College of Rheumatology 20% improvement criteria (ACR20)
The investigators use ACR20 to compared the difference between the week 8 and week 0
Secondary Outcome Measures
American College of Rheumatology 50% improvement criteria (ACR50)
The investigators use ACR50 to compared the difference between the week 8 and week 0
American College of Rheumatology 70% improvement criteria (ACR70)
The investigators use ACR70 to compared the difference between the week 8 and week 0
Disease activity score 28 (DAS28)
The investigators use DAS28 to compared the difference between the week 8 and week 0
European League Against Rheumatism (EULAR) response criteria
The investigators use EULAR responder rate to compared the difference between the week 8 and week 0
The number of tender and swollen joints
The investigators use the number of tender and swollen joints to compared the difference between the week 8 and week 0
Physician's global assessment (PhGA)
The investigators use PhGA to compared the difference between the week 8 and week 0
Patient's global assessment (PGA)
The investigators use PGA to compared the difference between the week 8 and week 0
Visual Analog Scale for pain (VAS)
The investigators use VAS to compared the difference between the week 8 and week 0
Quality of life by SF-36
The investigators use SF-36 to compared the difference between the week 8 and week 0
Full Information
NCT ID
NCT04144101
First Posted
October 28, 2019
Last Updated
October 28, 2019
Sponsor
Chung Shan Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04144101
Brief Title
Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2007 (Actual)
Primary Completion Date
July 31, 2007 (Actual)
Study Completion Date
July 31, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
etoricoxib aceclofenac efficacy safety Taiwanese
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Etoricoxib
Arm Type
Experimental
Arm Description
Etoricoxib 60 mg QD
Arm Title
Aceclofenac
Arm Type
Experimental
Arm Description
Aceclofenac 100 mg BID
Intervention Type
Drug
Intervention Name(s)
Etoricoxib
Other Intervention Name(s)
Arcoxia
Intervention Description
Etoricoxib 60 mg QD Oral
Intervention Type
Drug
Intervention Name(s)
Aceclofenac
Other Intervention Name(s)
TONEC
Intervention Description
Aceclofenac 100 mg BID Oral
Primary Outcome Measure Information:
Title
American College of Rheumatology 20% improvement criteria (ACR20)
Description
The investigators use ACR20 to compared the difference between the week 8 and week 0
Time Frame
week 0, week 8
Secondary Outcome Measure Information:
Title
American College of Rheumatology 50% improvement criteria (ACR50)
Description
The investigators use ACR50 to compared the difference between the week 8 and week 0
Time Frame
week 0, week 8
Title
American College of Rheumatology 70% improvement criteria (ACR70)
Description
The investigators use ACR70 to compared the difference between the week 8 and week 0
Time Frame
week 0, week 8
Title
Disease activity score 28 (DAS28)
Description
The investigators use DAS28 to compared the difference between the week 8 and week 0
Time Frame
week 0, week 8
Title
European League Against Rheumatism (EULAR) response criteria
Description
The investigators use EULAR responder rate to compared the difference between the week 8 and week 0
Time Frame
week 0, week 8
Title
The number of tender and swollen joints
Description
The investigators use the number of tender and swollen joints to compared the difference between the week 8 and week 0
Time Frame
week 0, week 8
Title
Physician's global assessment (PhGA)
Description
The investigators use PhGA to compared the difference between the week 8 and week 0
Time Frame
week 0, week 8
Title
Patient's global assessment (PGA)
Description
The investigators use PGA to compared the difference between the week 8 and week 0
Time Frame
week 0, week 8
Title
Visual Analog Scale for pain (VAS)
Description
The investigators use VAS to compared the difference between the week 8 and week 0
Time Frame
week 0, week 8
Title
Quality of life by SF-36
Description
The investigators use SF-36 to compared the difference between the week 8 and week 0
Time Frame
week 0, week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis as Rheumatoid Arthritis
Exclusion Criteria:
1. Pregnant or breast-feeding women. 2. Chemotherapy or radiation therapy in cancer patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng Ching Wei, Ph. D.
Organizational Affiliation
Chung Shan Medical University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis
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