Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis

NCT ID: NCT04144101

Last Updated: 2019-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-01
• Study Completion Date: 2007-07-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Etoricoxib

Etoricoxib 60 mg QD

Group Type: EXPERIMENTAL

Etoricoxib

Intervention Type: DRUG

Etoricoxib 60 mg QD Oral

Aceclofenac

Aceclofenac 100 mg BID

Group Type: EXPERIMENTAL

Aceclofenac

Intervention Type: DRUG

Aceclofenac 100 mg BID Oral

Interventions

Etoricoxib

Etoricoxib 60 mg QD Oral

Intervention Type: DRUG

Aceclofenac

Aceclofenac 100 mg BID Oral

Intervention Type: DRUG

Other Intervention Names

Arcoxia; TONEC

Eligibility Criteria

Inclusion Criteria

• Diagnosis as Rheumatoid Arthritis

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chung Shan Medical University

OTHER

Sponsor Role: lead

Responsible Party

Cheng-Chung Wei

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheng Ching Wei, Ph. D.

Role: STUDY_DIRECTOR

Chung Shan Medical University

Other Identifiers

CS07005

Identifier Type: -

Identifier Source: org_study_id