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A Study to Assess Etoricoxib Versus Diclofenac in Chinese Patients With Osteoarthritis of the Knee or Hip (0663-080)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00140972
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
A Study to Assess Etoricoxib versus Diclofenac in Chinese Patients with Osteoarthritis of the Knee or Hip

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: MK0663; etoricoxib / Duration of Treatment:4 Weeks Drug: Comparator: diclofenac sodium tablet 75 mg / Duration of Treatment:4 Weeks Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 3, 2004
Actual Primary Completion Date : June 27, 2005
Actual Study Completion Date : June 27, 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. WOMAC pain subscale

Secondary Outcome Measures :
  1. WOMAC Physical function subscale; WOMAC Stiffness subscale; Patient Global Assessment of Response to Therapy; Investigator Global Assessment of Disease Status

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chinese males or females at least 40 years of age with osteoarthritis of the knee or hip
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140972


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications of Results:
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.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00140972     History of Changes
Other Study ID Numbers: 0663-080
MK0663-080
2005_060
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Arcoxia

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diclofenac
Etoricoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors