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Completed

NCT Number: NCT00757627

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Etoricoxib

Drug

etoricoxib 60 mg QD for 4 weeks.

Other names: Arcoxia

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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).

  7. 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.

  8. Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4

    Time frame: Baseline and Week 4

  9. 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)

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Patient-reported Outcomes With Etoricoxib in Real Life

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 23, 2008
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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