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| ID | Type | Description | Link |
|---|---|---|---|
| MK0663-113 | |||
| 2008_029 |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Etoricoxib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etoricoxib | Drug | etoricoxib 60 mg QD for 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20536599 | Result | 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.1756-185X.2010.01468.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Etoricoxib | Etoricoxib 60 mg once a day (q.d.) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Etoricoxib | Etoricoxib 60 mg once a day (q.d.) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only patients with baseline and week 4 data were included in this analysis of change | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Week 4 |
|
From baseline to end of week 4
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etoricoxib | Etoricoxib 60 mg once a day (q.d.) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritoneal adhesion | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension / flatulence | Gastrointestinal disorders | Non-systematic Assessment |
Open-labeled, non-controlled
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077613 | Etoricoxib |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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| Baseline and Week 4 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4 | Baseline and Week 4 |
| 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 |
| Withdrawal by Subject |
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| Other |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Patient-SF36 (Short form 36) domain scores | 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). | Mean | Standard Deviation | Units on a scale |
|
| TSQM (Treatment Satisfaction Questionnaire for Medication )domain scores | 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. | Mean | Standard Deviation | Units on a scale |
|
| The mean of patient BPI (Brief Pain Inventory) scores | 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). | Mean | Standard Deviation | Units on a scale |
|
| The mean of patient WOMAC ( Western Ontario and McMaster Universities Osteoarthritis Index) subscale | 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. | Mean | Standard Deviation | Units on a Scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Only patients with baseline and week 4 data were included. | Posted | Number | Percentage of Participants | 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. | Per Protocol | Posted | Number | Percentage of Participants | Week 4 |
|
|
|
| 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") | 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. | Posted | Number | Percentage of Participants | Baseline and end of 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. | 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 | Posted | Number | Percentage of Participants | 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 | per protocol | Posted | Number | Percentage of participants | 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). | Only patients with both baseline and week 4 follow up data were included in this analysis. | Posted | Mean | Standard Deviation | Units on a Scale | 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. | 22 patients who reported side effects at baseline and week 4 were included in "side effect" evaluation. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Week 4 |
|
|
|
| Secondary | Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4 | Only patients with both baseline and week 4 data were included in this analysis. | Posted | Mean | Standard Deviation | Days | 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) | Intention to treat (ITT) | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Week 4 |
|
|
|
| 6 |
| 500 |
| 82 |
| 500 |
| Bacterial infection | Infections and infestations | Non-systematic Assessment |
|
| Lung abscess, chest pain/tightness and tremor | General disorders | Non-systematic Assessment |
|
| Traffic accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Urethritis | Renal and urinary disorders | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Abdominal pain, upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Edema , face/eye /hand/leg | Vascular disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Hypertension / elevated blood pressure | Vascular disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Palpitation | Cardiac disorders | Non-systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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.
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| Good Response |
|
| Excellent Response |
|
| Title | Measurements |
|---|
|
| Good response |
|
| Excellent response |
|
| Title | Measurements |
|---|---|
|
| Self care (n=499) No problem |
|
| Self care (n=499) Some problem |
|
| Self care (n=499) Not able to carry out |
|
| Daily activity (n=499) No problem |
|
| Daily activity (n=499) Some problem |
|
| Daily activity (n=499) Not able to carry out |
|
| Pain/Discomfort (n=500) Not present |
|
| Pain/Discomfort (n=500) Moderate |
|
| Pain/Discomfort (n=500) Extreme |
|
| Anxiety/Depressed (n=500) Not present |
|
| Anxiety/Depressed (n=500) Moderate |
|
| Anxiety/Depressed (n=500) Extreme |
|
| Title | Measurements |
|---|---|
|
| Self care (n=422) No problem |
|
| Self care (n=422) Some problem |
|
| Self care (n=422) Not able to carry out |
|
| Daily activity (n=421) No problem |
|
| Daily activity (n=421) Some problem |
|
| Daily activity (n=421) Not able to carry out |
|
| Pain/Discomfort (n=421) Not present |
|
| Pain/Discomfort (n=421) Moderate |
|
| Pain/Discomfort (n=421) Extreme |
|
| Anxiety/Depressed (n=422) Not present |
|
| Anxiety/Depressed (n=422) Moderate |
|
| Anxiety/Depressed (n=422) Extreme |
|
| Title | Measurements |
|---|---|
|
| BPI Pain right now (n=416) |
|
| BPI Interference on general activities (n=419) |
|
| BPI Interference on Mood (n=419) |
|
| BPI Interference on Walking (n=419) |
|
| BPI Interference on Normal work (n=419) |
|
| BPI Interference on Relations (n=418) |
|
| BPI Interference on Sleep (n=419) |
|
| BPI Interference on Enjoyment of life(n=419) |
|
| Title | Measurements |
|---|---|
|
| Overall (n=419) |
|
| Title | Measurements |
|---|---|
|
| SF36 General Health (n=419) |
|
| SF36 Vitality (n=417) |
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| SF36 Social Functioning (n=419) |
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| SF36 Role Limiting Due to Emotional Problem(n=418) |
|
| SF36 Mental Health (n=417) |
|