Rheumatoid ArthritisPhase 4NCT04144101
Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis
A Phase 4 study testing Etoricoxib and Aceclofenac in people with Rheumatoid Arthritis, run by Chung Shan Medical University.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Etoricoxib and Aceclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2007to 31 Jul 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis as Rheumatoid Arthritis
Who cannot join
- 1. Pregnant or breast-feeding women. 2. Chemotherapy or radiation therapy in cancer patients
About this study
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
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).
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Etoricoxib, Aceclofenac
- Keywords
- etoricoxib aceclofenac efficacy safety Taiwanese
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoricoxibDrug
Also called Arcoxia
Etoricoxib 60 mg QD Oral
AceclofenacDrug
Also called TONEC
Aceclofenac 100 mg BID Oral
| Study group | Role | What they receive |
|---|---|---|
| Etoricoxib | Experimental | Etoricoxib 60 mg QD Receives: Drug: Etoricoxib |
| Aceclofenac | Experimental | Aceclofenac 100 mg BID Receives: Drug: Aceclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
American College of Rheumatology 20% improvement criteria (ACR20)
The investigators use ACR20 to compared the difference between the week 8 and week 0
Measured: week 0, week 8
Secondary outcomes (9)
American College of Rheumatology 50% improvement criteria (ACR50)
The investigators use ACR50 to compared the difference between the week 8 and week 0
Measured: week 0, week 8
American College of Rheumatology 70% improvement criteria (ACR70)
The investigators use ACR70 to compared the difference between the week 8 and week 0
Measured: week 0, week 8
Disease activity score 28 (DAS28)
The investigators use DAS28 to compared the difference between the week 8 and week 0
Measured: week 0, week 8
European League Against Rheumatism (EULAR) response criteria
The investigators use EULAR responder rate to compared the difference between the week 8 and week 0
Measured: week 0, week 8
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
Measured: week 0, week 8
Physician's global assessment (PhGA)
The investigators use PhGA to compared the difference between the week 8 and week 0
Measured: week 0, week 8
Patient's global assessment (PGA)
The investigators use PGA to compared the difference between the week 8 and week 0
Measured: week 0, week 8
Visual Analog Scale for pain (VAS)
The investigators use VAS to compared the difference between the week 8 and week 0
Measured: week 0, week 8
Quality of life by SF-36
The investigators use SF-36 to compared the difference between the week 8 and week 0
Measured: week 0, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Mar 2007
- Primary completion31 Jul 2007
- Study completion31 Jul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng-Chung Wei, Chung Shan Medical University
- Investigators
- Cheng Ching Wei, Ph. D., Study director, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144101
- Sponsor's protocol ID
- CS07005
- Status last verified
- Oct 2019
- First submitted
- 28 Oct 2019
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04144101
- Acronym / sponsor ID
- CS07005
- Conditions
- Rheumatoid Arthritis
- Keywords
- etoricoxib aceclofenac efficacy safety Taiwanese
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2007 (actual)
- Primary completion
- 31 Jul 2007 (actual)
- Study completion
- 31 Jul 2007 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etoricoxib | Experimental | Drug: EtoricoxibEtoricoxib 60 mg QD |
| Aceclofenac | Experimental | Drug: AceclofenacAceclofenac 100 mg BID |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis as Rheumatoid Arthritis
Key exclusion criteria (1 listed)
- 1. Pregnant or breast-feeding women. 2. Chemotherapy or radiation therapy in cancer patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtoricoxibAlso: ArcoxiaEtoricoxib 60 mg QD Oral | Drug | Etoricoxib |
| AceclofenacAlso: TONECAceclofenac 100 mg BID Oral | Drug | Aceclofenac |
Primary outcome
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
9 secondary outcomes
American College of Rheumatology 50% improvement criteria (ACR50)
Time frame: week 0, week 8
American College of Rheumatology 70% improvement criteria (ACR70)
Time frame: week 0, week 8
Disease activity score 28 (DAS28)
Time frame: week 0, week 8
European League Against Rheumatism (EULAR) response criteria
Time frame: week 0, week 8
The number of tender and swollen joints
Time frame: week 0, week 8
Physician's global assessment (PhGA)
Time frame: week 0, week 8
Patient's global assessment (PGA)
Time frame: week 0, week 8
Visual Analog Scale for pain (VAS)
Time frame: week 0, week 8
Quality of life by SF-36
Time frame: week 0, week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng Ching Wei, Ph. D. study director
Chung Shan Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etoricoxib and Aceclofenac in people with Rheumatoid Arthritis, run by Chung Shan Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American College of Rheumatology 20% improvement criteria (ACR20) (time frame: week 0, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.