Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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")


Secondary Outcome Measures:
  • 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)


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

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 >= 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 22, 2008
Results First Received: January 4, 2010
Last Updated: April 16, 2014
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Etoricoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014