Patient-Reported Effectiveness and Safety of Etoricoxib in Osteoarthritis (OA)(0663-113)

NCT ID: NCT00757627

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-12-31

Brief Summary

The purpose of this study is to collect disease burden of OA and the effectiveness and patient satisfaction of treatment by Etoricoxib in the normal practice setting.

Conditions

Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Etoricoxib

Group Type: EXPERIMENTAL

etoricoxib

Intervention Type: DRUG

etoricoxib 60 mg QD for 4 weeks.

Interventions

etoricoxib

etoricoxib 60 mg QD for 4 weeks.

Intervention Type: DRUG

Other Intervention Names

Arcoxia

Eligibility Criteria

Inclusion Criteria

• Must Be Over 20 Years Of Age, Regardless Of Sex
• Must Have A Diagnosis Of OA That Requiring Treatment
• Patients Must Have Taken an NSAID, Cox-2 Or Opioids On The Majority Of Days During The Last 4 Weeks Before Enrollment Who Are Intolerant (Due To Gastrointestinal Adverse Events) Or Inadequately Respond To Current Therapy (Vas >= 40 mm On A Pain Scale From 0-100 mm)
• Excluding Osteoarthritis, The Patient Is Judged To Be In Otherwise General Good Health Based On Medical History, Physical Examination, And Routine Laboratory Tests
• Must Agree To Participate Voluntarily In The Study
• Must Have The Capacity To Understand And Answer The Questionnaires Used In The Study
• Must Agree To Return For A Follow-Up Visit With The Treating Physician Four Weeks After The Initiation Of Treatment With Etoricoxib
• Patient Is Willing To Sign Informed Consent Form

Exclusion Criteria

• Under 20 Years Of Age
• Severe Hepatic Insufficiency (Child-Pugh Score > 9)
• Advanced Renal Insufficiency (Creatinine Clearance < 30 Ml/Min)
• Any Contraindication Or Warning Or Precaution As Mentioned In The Approved Study Drug Package Insert
• Gi Ulcer With Active Bleeding Present At Study Enrollment
• Patient Has A Recent History Of Stroke, Myocardial Infarction Or Transient Ischemic Attack (Within The Previous 2 Years)

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

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Lin HY, Cheng TT, Wang JH, Lee CS, Chen MH, Lei V, Lac C, Gammaitoni AR, Smugar SS, Chen WJ. Etoricoxib improves pain, function and quality of life: results of a real-world effectiveness trial. Int J Rheum Dis. 2010 May;13(2):144-50. doi: 10.1111/j.1756-185X.2010.01468.x.

Reference Type: RESULT

PMID: 20536599 (View on PubMed)

Other Identifiers

MK0663-113

Identifier Type: -

Identifier Source: secondary_id

2008_029

Identifier Type: -

Identifier Source: secondary_id

0663-113

Identifier Type: -

Identifier Source: org_study_id