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Related Studies
Patient-Reported Effectiveness and Safety of Arcoxia in Osteoarthritis (OA)
This study is ongoing, but not recruiting participants.
First Received: September 22, 2008   Last Updated: October 6, 2008   History of Changes
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00757627
  Purpose

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


Condition Intervention Phase
Pain
Drug: Etoricoxib (Arcoxia )
Phase IV

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Etoricoxib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Patient-Reported Outcomes With Etoricoxib in Real Life

Further study details as provided by Merck:

Primary Outcome Measures:
  • Patient: WOMAC; Brief Pain Inventory EQ-5D; TSQM; Disease impact on work; SF-36 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physician: IGART (Investigator Global Assessment of Response to Therapy) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: December 2007
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Etoricoxib (Arcoxia )
    Etoricoxib; 60 mg QD for 4 weeks.
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 D 40mm On A Pain Scale From 0-100mm)
  • Excepting 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757627

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2008_029, MK0663-113
Study First Received: September 22, 2008
Last Updated: October 6, 2008
ClinicalTrials.gov Identifier: NCT00757627     History of Changes
Health Authority: Taiwan: National Bureau of Controlled Drugs

Study placed in the following topic categories:
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Osteoarthritis
Cyclooxygenase Inhibitors
Etoricoxib
Anti-Inflammatory Agents, Non-Steroidal
Pain
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Etoricoxib
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009