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

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00757627

First received: September 22, 2008

Last updated: April 20, 2010

Last verified: April 2010

History of Changes

Results First Received: January 4, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Pain
Intervention:	Drug: etoricoxib

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Etoricoxib	Etoricoxib 60 mg once a day (q.d.)

Participant Flow: Overall Study

	Etoricoxib
STARTED	500
COMPLETED	419
NOT COMPLETED	81
Adverse Event	15
Lack of Efficacy	10
Lost to Follow-up	28
Withdrawal by Subject	27
Unspecified	1

Baseline Characteristics

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Reporting Groups

	Description
Etoricoxib	Etoricoxib 60 mg once a day (q.d.)

Baseline Measures

	Etoricoxib
Number of Participants [units: participants]	500
Age [units: years] Mean ± Standard Deviation	66.6 ± 10.9
Gender [units: participants]
Female	365
Male	135
Patient-SF36 (Short form 36) domain scores ^[1] [units: 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 ^[2] [units: 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 ^[3] [units: 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 ^[4] [units: 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

[1]	SF36 consists of weighted scores of the 8 domains (physical functioning; role limitation due to physical problem; bodily pain; general health; vitality; social functioning; role limitation due to emotional problem; mental health), each is measured with scale score ranged from 0≈100, with 100 representing the best possible functioning).
[2]	TSQM consists of four domains (effectiveness; side effect; convenience and overall satisfaction), domain scores ranged from 0(0=worst) -100(100=best) were derived from converting the original Likert's scales to VAS scale.
[3]	BPI consists of pain and pain interference domains. For pain (0=no pain to 10=extreme pain); for Interference ( 0=no interference to 10= greatest interference).
[4]	The baseline domain scores of WOMAC included pain, stiffness, and difficult in doing daily activity. 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.

Outcome Measures

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1. 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 [ Time Frame: Baseline and end of week 4 ]

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2. Secondary:

Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4 [ Time Frame: Baseline and Week 4 ]

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3. Secondary:

Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy) [ Time Frame: Baseline ]

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4. Secondary:

Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART [ Time Frame: Week 4 ]

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5. Secondary:

Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline [ Time Frame: Baseline ]

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6. Secondary:

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

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Measure Type	Secondary
Measure Title	Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
per protocol

Reporting Groups

	Description
Week 4 - EQ-5D	No text entered.

Measured Values

	Week 4 - EQ-5D
Number of Participants Analyzed [units: participants]	423
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4 [units: Percentage of participants]
Motility (423) No problem	67.61
Motility (423) Some problem	32.39
Motility (423) Not able to carry out	0.00
Self care (422) No problem	90.05
Self care (422) Some problem	9.48
Self care (422) Not able to carry out	0.47
Daily activity (421) No problem	61.76
Daily activity (421) Some problem	37.29
Daily activity (421) Not able to carry out	0.95
Pain/Discomfort (421) Not present	23.04
Pain/Discomfort (421) Moderate	73.63
Pain/Discomfort (421) Extreme	3.33
Anxiety/Depressed (422) Not present	61.37
Anxiety/Depressed (422) Moderate	36.97
Anxiety/Depressed (422) Extreme	1.66

No statistical analysis provided for Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4

7. Secondary:

Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4 [ Time Frame: Baseline and Week 4 ]

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8. Secondary:

Patient TSQM (Treatment Satisfaction Questionnaire for Medication) [ Time Frame: Baseline and Week 4 ]

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9. Secondary:

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

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10. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Open-labeled, non-controlled

Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00757627 History of Changes
Other Study ID Numbers:	2008_029, MK0663-113
Study First Received:	September 22, 2008
Results First Received:	January 4, 2010
Last Updated:	April 20, 2010
Health Authority:	Taiwan: Department of Health

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