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

Pain Clinical Trial

Official title:

Patient-reported Outcomes With Etoricoxib in Real Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757627
• Other study ID #: 0663-113
• Secondary ID: MK0663-1132008_0
• Status: Completed
• Phase: Phase 4
• Start date: December 2007
• Est. completion date: December 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• etoricoxib
etoricoxib 60 mg QD for 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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.1756-1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	WOMAC for pain assessment by patient (0-100 mm Visual Analog Scale (VAS) with 0 represent "no pain" and 100 represent "extreme pain")	Baseline and end of week 4
Secondary	Mean Change From Baseline in Patient WOMAC Domain Scores at 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.	Baseline and Week 4
Secondary	Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)	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.	Baseline
Secondary	Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART	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.	Week 4
Secondary	Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at 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.	Baseline
Secondary	Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at 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	Week 4
Secondary	Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at 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).	Baseline and Week 4
Secondary	Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at 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.	Baseline and Week 4
Secondary	Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4		Baseline and Week 4
Secondary	Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at 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)	Baseline and Week 4