Back to resultsA Study to Assess Etoricoxib Versus Diclofenac in Chinese Patients With Osteoarthritis of the Knee or Hip (0663-080)(COMPLETED)
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MK0663; etoricoxib / Duration of Treatment:4 Weeks
Comparator: diclofenac sodium tablet 75 mg / Duration of Treatment:4 Weeks
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Arcoxia
Eligibility Criteria
Inclusion Criteria: Chinese males or females at least 40 years of age with osteoarthritis of the knee or hip
Sites / Locations
Outcomes
Primary Outcome Measures
WOMAC pain subscale
Secondary Outcome Measures
WOMAC Physical function subscale; WOMAC Stiffness subscale; Patient Global Assessment of Response to Therapy; Investigator Global Assessment of Disease Status
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00140972
Brief Title
A Study to Assess Etoricoxib Versus Diclofenac in Chinese Patients With Osteoarthritis of the Knee or Hip (0663-080)(COMPLETED)
Official Title
A Multicenter, Randomized, Parallel-group, 4-Week, Double-Blind and Active Comparator-Controlled Study to Assess Efficacy, Safety, and Tolerability of Etoricoxib 60 mg Once Daily Versus Diclofenac Sodium 75 mg Twice Daily in the Treatment of Chinese Patients With Osteoarthritis of the Knee or Hip
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 3, 2004 (Actual)
Primary Completion Date
June 27, 2005 (Actual)
Study Completion Date
June 27, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief Summary
A Study to Assess Etoricoxib versus Diclofenac in Chinese Patients with Osteoarthritis of the Knee or Hip
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Arcoxia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0663; etoricoxib / Duration of Treatment:4 Weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: diclofenac sodium tablet 75 mg / Duration of Treatment:4 Weeks
Primary Outcome Measure Information:
Title
WOMAC pain subscale
Secondary Outcome Measure Information:
Title
WOMAC Physical function subscale; WOMAC Stiffness subscale; Patient Global Assessment of Response to Therapy; Investigator Global Assessment of Disease Status
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chinese males or females at least 40 years of age with osteoarthritis of the knee or hip
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
Citation
Zhang F, Li Z, Yang N, Wu D, Sun L, Wu H. The clinical study of etoricoxib in the treatment of Chinese patients with osteoarthritis: a randomized double-blind trial. Chinese J of Rheum. 2013;17(5):307-312.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
A Study to Assess Etoricoxib Versus Diclofenac in Chinese Patients With Osteoarthritis of the Knee or Hip (0663-080)(COMPLETED)
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