Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04144101
• Other study ID #: CS07005
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

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