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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00757627
First received: September 22, 2008
Last updated: April 16, 2014
Last verified: April 2014

September 22, 2008
April 16, 2014
December 2007
December 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
WOMAC for pain assessment by patient (0-100 mm Visual Analog Scale (VAS) with 0 represent "no pain" and 100 represent "extreme pain")
Patient: WOMAC; Brief Pain Inventory EQ-5D; TSQM; Disease impact on work; SF-36 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00757627 on ClinicalTrials.gov Archive Site
  • Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    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)
Physician: IGART (Investigator Global Assessment of Response to Therapy) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Patient-Reported Effectiveness and Safety of Etoricoxib in Osteoarthritis (OA)(0663-113)
Patient-reported Outcomes With Etoricoxib in Real Life

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
Drug: etoricoxib
etoricoxib 60 mg QD for 4 weeks.
Other Name: Arcoxia
Experimental: 1
Etoricoxib
Intervention: Drug: etoricoxib
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
December 2008
December 2008   (final data collection date for primary outcome measure)

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)
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00757627
0663-113, MK0663-113, 2008_029
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP