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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00757627
First Posted: September 23, 2008
Last Update Posted: August 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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.

Condition Intervention Phase
Pain Drug: etoricoxib Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient-reported Outcomes With Etoricoxib in Real Life

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The Percentage of Participants Achieving ≥30% Decrease From Baseline in Pain Intensity as Measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Question 1 "Pain Walking on a Flat Surface" at Week 4 [ Time Frame: Baseline and end of week 4 ]
    WOMAC for pain assessment by patient (0-100 mm Visual Analog Scale (VAS) with 0 represent "no pain" and 100 represent "extreme pain")


Secondary Outcome Measures:
  • Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4 [ Time Frame: Baseline and Week 4 ]
    The change from baseline in 3 domain scores (pain, stiffness, and difficult in doing daily activity) of WOMAC at week 4 were measured. Each domain comprises of questions and VAS scales for scoring. For pain domain, 0 represents no pain and 100 represents extreme pain; for stiffness domain, 0 represents no stiffness and 100 represents extreme stiffness; for difficult in doing daily activity domain, 0 represents no difficulty and 100 represents most difficulty.

  • Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy) [ Time Frame: Baseline ]
    The IGART comprised of five categories: No response, poor response, fair response, good response, and excellent response. The percentage of participants who met the criteria of any of the 5 categories at baseline were collected.

  • Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART [ Time Frame: Week 4 ]
    The IGART comprised of five categories: No response, poor response, fair response, good response, and excellent response. The percentage of participants met the criteria of any of the 5 categories at week 4 were collected.

  • Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline [ Time Frame: Baseline ]
    The percentage of participants who met the criteria of any of the 3 categories of EQ-5D at baseline and at week 4 were collected.The EQ-5D comprises of 5 dimensions (mobility, self-care, usual activities, pain / discomfort, and anxiety / depression) to be answered using a 3-categorical Likert's scales of: [No problem, Some problem, and Not able to carry out] for mobility, self-care and usual activities and [Not present, moderate and extreme] for discomfort and anxiety/depression.

  • Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4 [ Time Frame: Week 4 ]
    The percentage of participants who met the criteria of any of the 3 categories of EQ-5D at baseline and at week 4 were collected.The EQ-5D comprises of 5 dimensions (mobility, self-care, usual activities, pain / discomfort, and anxiety / depression) to be answered using a 3-categorical Likert's scales of: [No problem, Some problem, and Not able to carry out] for mobility, self-care and usual activities and [ Not present, moderate and extreme]for discomfort and anxiety/depression

  • Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4 [ Time Frame: Baseline and Week 4 ]
    BPI consists of pain and pain interference domains. For pain (0=no pain to 10=extreme pain); for pain interference ( 0=no interference to 10= greatest interference).

  • Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at Week 4 [ Time Frame: Baseline and Week 4 ]
    TSQM consists of four domains (effectiveness; side effect; convenience and overall satisfaction), domain scores ranged from 0 (0=worst) to 100 (100=best) were derived from converting the original Likert's scales to VAS scale.

  • Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4 [ Time Frame: Baseline and Week 4 ]
  • Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4 [ Time Frame: Baseline and Week 4 ]
    Weighted scores of the 8 domains of SF36 (i.e., physical functioning; role limiting due to physical problem; bodily pain; general health; vitality; social functioning; role limiting due to emotional problem; mental health) were scored on a scale from 0 ~100, with 100 representing the best possible functioning)


Enrollment: 500
Study Start Date: December 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Etoricoxib
Drug: etoricoxib
etoricoxib 60 mg QD for 4 weeks.
Other Name: Arcoxia

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 >= 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)
  Contacts and Locations
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): NCT00757627


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00757627     History of Changes
Other Study ID Numbers: 0663-113
MK0663-113
2008_029
First Submitted: September 22, 2008
First Posted: September 23, 2008
Results First Submitted: January 4, 2010
Results First Posted: May 11, 2010
Last Update Posted: August 14, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
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