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

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00757627
• Collaborator: (none)
• Enrollment: 500
• Arm: 1
• Duration (Months): 12

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: etoricoxib	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 500 participants
• 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
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Etoricoxib	Drug: etoricoxib; etoricoxib 60 mg QD for 4 weeks.; Other Names: Arcoxia

Outcome Measures

Primary Outcome Measures

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 [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

1. Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4 [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) [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 [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 [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 [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 [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 [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 [Baseline and Week 4]

9. Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4 [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00757627
• Other Study ID Numbers: 0663-113; MK0663-113; 2008_029
• First Posted: Sep 23, 2008
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Etoricoxib

Study Results

Participant Flow

Arm/Group Title	Etoricoxib
Arm/Group Description	Etoricoxib 60 mg once a day (q.d.)
Period Title: Overall Study
STARTED	500
COMPLETED	419
NOT COMPLETED	81

Baseline Characteristics

Arm/Group Title	Etoricoxib
Arm/Group Description	Etoricoxib 60 mg once a day (q.d.)
Overall Participants	500
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.6 (10.9)
Sex: Female, Male (Count of Participants)
Female	365 73%
Male	135 27%
Patient-SF36 (Short form 36) domain scores (Units on a scale) [Mean (Standard Deviation) ]
SF-36 Physical functional	45.1 (51.3)
SF-36 Role limitation due to physical problem	24.0 (42.5)
SF-36 Bodily pain	52.4 (63.9)
SF-36 General health	52.7 (54.5)
SF-36 Vitality	55.9 (57.6)
SF-36 Social functioning	69.0 (78.3)
SF-36 Role limitation due to emotional problem	41.3 (56.6)
SF-36 Mental health	61.7 (66.3)
TSQM (Treatment Satisfaction Questionnaire for Medication )domain scores (Units on a scale) [Mean (Standard Deviation) ]
TSQM - Effectiveness	52.1 (55.6)
TSQM - Side effect	56.9 (55.7)
TSQM - Convenience	68.0 (68.8)
TSQM - Overall satisfaction	44.1 (45.7)
The mean of patient BPI (Brief Pain Inventory) scores (Units on a scale) [Mean (Standard Deviation) ]
BPI -Worst pain	6.4 (4.9)
BPI -Least pain	3.2 (2.5)
BPI-Average pain	4.9 (3.8)
BPI -Pain right now	4.4 (3.1)
BPI -Interference on general activities	2.9 (2.1)
BPI - Mood	3.2 (2.2)
BPI -Walking	4.3 (2.9)
BPI - Normal work	4.2 (2.9)
BPI- Relations with other people	2.5 (1.9)
BPI - Sleep	3.3 (2.3)
BPI - Enjoyment of life	3.0 (2.1)
The mean of patient WOMAC ( Western Ontario and McMaster Universities Osteoarthritis Index) subscale (Units on a Scale) [Mean (Standard Deviation) ]
WOMAC Pain subscale	38.5 (22.9)
WOMAC Stiffness subscale	36.3 (26.9)
WOMAC Physical Function subscale	38.0 (24.8)

Outcome Measures

1. Secondary Outcome

Title	Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4
Description	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.
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description

Only patients with baseline and week 4 data were included in this analysis of change

Arm/Group Title	Etoricoxib
Arm/Group Description	Etoricoxib 60 mg q.d.
Measure Participants	418
WOMAC Pain subscale (n=418)	-10.0 (20.5)
WOMAC Stiffness subscale (n=418)	-7.9 (25.7)
WOMAC Physical Function subscale (n=416)	-8.0 (19.6)

2. Secondary Outcome

Title	Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Only patients with baseline and week 4 data were included.

Arm/Group Title	Etoricoxib (Baseline)
Arm/Group Description	Etoricoxib 60 mg q.d.
Measure Participants	500
No Response	4.40 0.9%
Poor Response	57.60 11.5%
Fair Response	36.40 7.3%
Good Response	1.60 0.3%
Excellent Response	0.00 0%

3. Secondary Outcome

Title	Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART
Description	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.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	Etoricoxib (Week 4)
Arm/Group Description	Etoricoxib 60 mg q.d.
Measure Participants	430
No response	5.81 1.2%
Poor response	16.05 3.2%
Fair response	35.35 7.1%
Good response	36.74 7.3%
Excellent response	6.05 1.2%

4. Primary Outcome

Title	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
Description	WOMAC for pain assessment by patient (0-100 mm Visual Analog Scale (VAS) with 0 represent "no pain" and 100 represent "extreme pain")
Time Frame	Baseline and end of week 4

Outcome Measure Data

Analysis Population Description

Per protocol (all patients who completed the WOMAC"pain walking on a flat surface " question at baseline and follow up visit at week 4 will be included for analysis of this endpoint. Among the 419 patients with follow up visit data, 27 patients rated 0 in their VAS pain score at baseline and were excluded from this analysis.

Arm/Group Title	Etoricoxib
Arm/Group Description	Etoricoxib 60 mg q.d.
Measure Participants	392
Number [Percentage of Participants]	52.04 10.4%

5. Secondary Outcome

Title	Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Only patients with baseline and week 4 data were included in the analysis. Week 4 N Values; Motility 423 , Self care 422 , Daily Activity 421 , Pain/Discomfort 421 , Anxiety/Depressed 422

Arm/Group Title	Baseline - EQ-5D
Arm/Group Description
Measure Participants	500
Motility (n=499) No problem	54.91 11%
Motility (n=499) Some problem	45.09 9%
Motility (n=499) Not able to carry out	0.00 0%
Self care (n=499) No problem	86.97 17.4%
Self care (n=499) Some problem	12.63 2.5%
Self care (n=499) Not able to carry out	0.40 0.1%
Daily activity (n=499) No problem	54.91 11%
Daily activity (n=499) Some problem	43.69 8.7%
Daily activity (n=499) Not able to carry out	1.40 0.3%
Pain/Discomfort (n=500) Not present	10.00 2%
Pain/Discomfort (n=500) Moderate	79.60 15.9%
Pain/Discomfort (n=500) Extreme	10.40 2.1%
Anxiety/Depressed (n=500) Not present	51.60 10.3%
Anxiety/Depressed (n=500) Moderate	44.00 8.8%
Anxiety/Depressed (n=500) Extreme	4.40 0.9%

6. Secondary Outcome

Title	Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
Description	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
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

per protocol

Arm/Group Title	Week 4 - EQ-5D
Arm/Group Description
Measure Participants	423
Motility (n=423) No problem	67.61 13.5%
Motility (n=423) Some problem	32.39 6.5%
Motility (n=423) Not able to carry out	0.00 0%
Self care (n=422) No problem	90.05 18%
Self care (n=422) Some problem	9.48 1.9%
Self care (n=422) Not able to carry out	0.47 0.1%
Daily activity (n=421) No problem	61.76 12.4%
Daily activity (n=421) Some problem	37.29 7.5%
Daily activity (n=421) Not able to carry out	0.95 0.2%
Pain/Discomfort (n=421) Not present	23.04 4.6%
Pain/Discomfort (n=421) Moderate	73.63 14.7%
Pain/Discomfort (n=421) Extreme	3.33 0.7%
Anxiety/Depressed (n=422) Not present	61.37 12.3%
Anxiety/Depressed (n=422) Moderate	36.97 7.4%
Anxiety/Depressed (n=422) Extreme	1.66 0.3%

7. Secondary Outcome

Title	Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4
Description	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).
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description

Only patients with both baseline and week 4 follow up data were included in this analysis.

Arm/Group Title	Etoricoxib
Arm/Group Description	Etoricoxib 60 mg q.d.
Measure Participants	419
BPI Worst pain (n=418)	-1.5 (2.4)
BPI Least pain (n=417)	-0.6 (2.2)
BPI Average pain (n=419)	-1.0 (2.0)
BPI Pain right now (n=416)	-1.3 (2.6)
BPI Interference on general activities (n=419)	-0.8 (2.5)
BPI Interference on Mood (n=419)	-1.0 (2.7)
BPI Interference on Walking (n=419)	-1.2 (2.5)
BPI Interference on Normal work (n=419)	-1.1 (2.8)
BPI Interference on Relations (n=418)	-0.6 (2.6)
BPI Interference on Sleep (n=419)	-1.0 (2.8)
BPI Interference on Enjoyment of life(n=419)	-0.8 (2.7)

8. Secondary Outcome

Title	Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at Week 4
Description	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.
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description

22 patients who reported side effects at baseline and week 4 were included in "side effect" evaluation.

Arm/Group Title	Etoricoxib
Arm/Group Description	Etoricoxib 60 mg q.d.
Measure Participants	419
Effectiveness ((n=418)	2.8 (17.0)
Side Effect (n=22)	-3.8 (16.4)
Convenience (n=418)	0.9 (10.8)
Overall (n=419)	1.1 (20.9)

9. Secondary Outcome

Title	Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description

Only patients with both baseline and week 4 data were included in this analysis.

Arm/Group Title	Etoricoxib
Arm/Group Description	Etoricoxib 60 mg q.d.
Measure Participants	411
Days Missed From Work (n=138)	-0.4 (1.6)
Days Missed From Housekeeping Work (n=411)	-2.3 (6.8)

10. Secondary Outcome

Title	Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4
Description	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)
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description

Intention to treat (ITT)

Arm/Group Title	Etoricoxib 60 mg q.d.
Arm/Group Description
Measure Participants	419
SF36 Physical Functioning (n=418)	5.2 (19.9)
SF36 Role Limiting Due to Physical Problem (n=418)	17.6 (49.3)
SF36 Bodily Pain (n=418)	10.6 (17.7)
SF36 General Health (n=419)	2.0 (16.2)
SF36 Vitality (n=417)	1.4 (15.1)
SF36 Social Functioning (n=419)	8.7 (20.3)
SF36 Role Limiting Due to Emotional Problem(n=418)	14.0 (50.4)
SF36 Mental Health (n=417)	4.4 (14.0)

Adverse Events

Time Frame	From baseline to end of week 4
Arm/Group Title	Etoricoxib
Arm/Group Description	Etoricoxib 60 mg once a day (q.d.)
All Cause Mortality
	Etoricoxib
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Etoricoxib
	Affected / at Risk (%)	# Events
Total	6/500 (1.2%)
Gastrointestinal disorders
Peritoneal adhesion	1/500 (0.2%)	1
General disorders
Lung abscess, chest pain/tightness and tremor	1/500 (0.2%)	1
Infections and infestations
Bacterial infection	1/500 (0.2%)	1
Injury, poisoning and procedural complications
Traffic accident	1/500 (0.2%)	1
Renal and urinary disorders
Urethritis	1/500 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory failure	1/500 (0.2%)	1
Other (Not Including Serious) Adverse Events
	Etoricoxib
	Affected / at Risk (%)	# Events
Total	82/500 (16.4%)
Cardiac disorders
Palpitation	8/500 (1.6%)	8
Gastrointestinal disorders
Abdominal distension / flatulence	6/500 (1.2%)	6
Abdominal pain, upper	6/500 (1.2%)	6
Nausea	6/500 (1.2%)	6
Nervous system disorders
Dizziness	11/500 (2.2%)	12
Headache	5/500 (1%)	5
Skin and subcutaneous tissue disorders
Skin rash	7/500 (1.4%)	7
Vascular disorders
Edema , face/eye /hand/leg	24/500 (4.8%)	24
Hypertension / elevated blood pressure	9/500 (1.8%)	9

Limitations/Caveats

Open-labeled, non-controlled

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.