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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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7.  Secondary:   Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4   [ Time Frame: Baseline and Week 4 ]
  Show Outcome Measure 7

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 ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4   [ Time Frame: Baseline and Week 4 ]
  Show Outcome Measure 10


  Serious Adverse Events
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  Other Adverse Events
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Time Frame From baseline to end of week 4
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   1%  

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

Other Adverse Events
    Etoricoxib  
Total, other (not including serious) adverse events    
# participants affected / at risk     82/500  
Cardiac disorders    
Palpitation *  
# participants affected / at risk     8/500 (1.60%)  
# events     8  
Gastrointestinal disorders    
Abdominal distension / flatulence *  
# participants affected / at risk     6/500 (1.20%)  
# events     6  
Abdominal pain, upper *  
# participants affected / at risk     6/500 (1.20%)  
# events     6  
Nausea *  
# participants affected / at risk     6/500 (1.20%)  
# events     6  
Nervous system disorders    
Dizziness *  
# participants affected / at risk     11/500 (2.20%)  
# events     12  
Headache *  
# participants affected / at risk     5/500 (1.00%)  
# events     5  
Skin and subcutaneous tissue disorders    
Skin rash *  
# participants affected / at risk     7/500 (1.40%)  
# events     7  
Vascular disorders    
Edema , face/eye /hand/leg *  
# participants affected / at risk     24/500 (4.80%)  
# events     24  
Hypertension / elevated blood pressure *  
# participants affected / at risk     9/500 (1.80%)  
# events     9  
* Events were collected by non-systematic assessment



  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:
unchecked 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.
unchecked 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.


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