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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04144101
Other study ID # CS07005
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 1, 2007
Est. completion date July 31, 2007

Study information

Verified date October 2019
Source Chung Shan Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 31, 2007
Est. primary completion date July 31, 2007
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Diagnosis as Rheumatoid Arthritis

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Etoricoxib
Etoricoxib 60 mg QD Oral
Aceclofenac
Aceclofenac 100 mg BID Oral

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chung Shan Medical University

Outcome

Type Measure Description Time frame Safety issue
Primary American College of Rheumatology 20% improvement criteria (ACR20) The investigators use ACR20 to compared the difference between the week 8 and week 0 week 0, week 8
Secondary American College of Rheumatology 50% improvement criteria (ACR50) The investigators use ACR50 to compared the difference between the week 8 and week 0 week 0, week 8
Secondary American College of Rheumatology 70% improvement criteria (ACR70) The investigators use ACR70 to compared the difference between the week 8 and week 0 week 0, week 8
Secondary Disease activity score 28 (DAS28) The investigators use DAS28 to compared the difference between the week 8 and week 0 week 0, week 8
Secondary European League Against Rheumatism (EULAR) response criteria The investigators use EULAR responder rate to compared the difference between the week 8 and week 0 week 0, week 8
Secondary 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 week 0, week 8
Secondary Physician's global assessment (PhGA) The investigators use PhGA to compared the difference between the week 8 and week 0 week 0, week 8
Secondary Patient's global assessment (PGA) The investigators use PGA to compared the difference between the week 8 and week 0 week 0, week 8
Secondary Visual Analog Scale for pain (VAS) The investigators use VAS to compared the difference between the week 8 and week 0 week 0, week 8
Secondary Quality of life by SF-36 The investigators use SF-36 to compared the difference between the week 8 and week 0 week 0, week 8
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