Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT00757627
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2008-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Patient-Reported Effectiveness and Safety of Etoricoxib in Osteoarthritis (OA)(0663-113)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Taiwan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077613', 'term': 'Etoricoxib'}], 'ancestors': [{'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Open-labeled, non-controlled'}}, 'adverseEventsModule': {'timeFrame': 'From baseline to end of week 4', 'eventGroups': [{'id': 'EG000', 'title': 'Etoricoxib', 'description': 'Etoricoxib 60 mg once a day (q.d.)', 'otherNumAtRisk': 500, 'otherNumAffected': 82, 'seriousNumAtRisk': 500, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Abdominal distension / flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain, upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema , face/eye /hand/leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension / elevated blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Peritoneal adhesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung abscess, chest pain/tightness and tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urethritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib', 'description': 'Etoricoxib 60 mg q.d.'}], 'classes': [{'title': 'WOMAC Pain subscale (n=418)', 'categories': [{'measurements': [{'value': '-10.0', 'spread': '20.5', 'groupId': 'OG000'}]}]}, {'title': 'WOMAC Stiffness subscale (n=418)', 'categories': [{'measurements': [{'value': '-7.9', 'spread': '25.7', 'groupId': 'OG000'}]}]}, {'title': 'WOMAC Physical Function subscale (n=416)', 'categories': [{'measurements': [{'value': '-8.0', 'spread': '19.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 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.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with baseline and week 4 data were included in this analysis of change'}, {'type': 'SECONDARY', 'title': "Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib (Baseline)', 'description': 'Etoricoxib 60 mg q.d.'}], 'classes': [{'title': 'No Response', 'categories': [{'measurements': [{'value': '4.40', 'groupId': 'OG000'}]}]}, {'title': 'Poor Response', 'categories': [{'measurements': [{'value': '57.60', 'groupId': 'OG000'}]}]}, {'title': 'Fair Response', 'categories': [{'measurements': [{'value': '36.40', 'groupId': 'OG000'}]}]}, {'title': 'Good Response', 'categories': [{'measurements': [{'value': '1.60', 'groupId': 'OG000'}]}]}, {'title': 'Excellent Response', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', '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.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with baseline and week 4 data were included.'}, {'type': 'SECONDARY', 'title': "Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART", 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib (Week 4)', 'description': 'Etoricoxib 60 mg q.d.'}], 'classes': [{'title': 'No response', 'categories': [{'measurements': [{'value': '5.81', 'groupId': 'OG000'}]}]}, {'title': 'Poor response', 'categories': [{'measurements': [{'value': '16.05', 'groupId': 'OG000'}]}]}, {'title': 'Fair response', 'categories': [{'measurements': [{'value': '35.35', 'groupId': 'OG000'}]}]}, {'title': 'Good response', 'categories': [{'measurements': [{'value': '36.74', 'groupId': 'OG000'}]}]}, {'title': 'Excellent response', 'categories': [{'measurements': [{'value': '6.05', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', '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.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol'}, {'type': 'PRIMARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib', 'description': 'Etoricoxib 60 mg q.d.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.04', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and end of 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")', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.\n\nAmong 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.'}, {'type': 'SECONDARY', 'title': 'Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline - EQ-5D'}], 'classes': [{'title': 'Motility (n=499) No problem', 'categories': [{'measurements': [{'value': '54.91', 'groupId': 'OG000'}]}]}, {'title': 'Motility (n=499) Some problem', 'categories': [{'measurements': [{'value': '45.09', 'groupId': 'OG000'}]}]}, {'title': 'Motility (n=499) Not able to carry out', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Self care (n=499) No problem', 'categories': [{'measurements': [{'value': '86.97', 'groupId': 'OG000'}]}]}, {'title': 'Self care (n=499) Some problem', 'categories': [{'measurements': [{'value': '12.63', 'groupId': 'OG000'}]}]}, {'title': 'Self care (n=499) Not able to carry out', 'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000'}]}]}, {'title': 'Daily activity (n=499) No problem', 'categories': [{'measurements': [{'value': '54.91', 'groupId': 'OG000'}]}]}, {'title': 'Daily activity (n=499) Some problem', 'categories': [{'measurements': [{'value': '43.69', 'groupId': 'OG000'}]}]}, {'title': 'Daily activity (n=499) Not able to carry out', 'categories': [{'measurements': [{'value': '1.40', 'groupId': 'OG000'}]}]}, {'title': 'Pain/Discomfort (n=500) Not present', 'categories': [{'measurements': [{'value': '10.00', 'groupId': 'OG000'}]}]}, {'title': 'Pain/Discomfort (n=500) Moderate', 'categories': [{'measurements': [{'value': '79.60', 'groupId': 'OG000'}]}]}, {'title': 'Pain/Discomfort (n=500) Extreme', 'categories': [{'measurements': [{'value': '10.40', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety/Depressed (n=500) Not present', 'categories': [{'measurements': [{'value': '51.60', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety/Depressed (n=500) Moderate', 'categories': [{'measurements': [{'value': '44.00', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety/Depressed (n=500) Extreme', 'categories': [{'measurements': [{'value': '4.40', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '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.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with baseline and week 4 data were included in the analysis.\n\nWeek 4 N Values; Motility 423 , Self care 422 , Daily Activity 421 , Pain/Discomfort 421 , Anxiety/Depressed 422'}, {'type': 'SECONDARY', 'title': 'Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Week 4 - EQ-5D'}], 'classes': [{'title': 'Motility (n=423) No problem', 'categories': [{'measurements': [{'value': '67.61', 'groupId': 'OG000'}]}]}, {'title': 'Motility (n=423) Some problem', 'categories': [{'measurements': [{'value': '32.39', 'groupId': 'OG000'}]}]}, {'title': 'Motility (n=423) Not able to carry out', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Self care (n=422) No problem', 'categories': [{'measurements': [{'value': '90.05', 'groupId': 'OG000'}]}]}, {'title': 'Self care (n=422) Some problem', 'categories': [{'measurements': [{'value': '9.48', 'groupId': 'OG000'}]}]}, {'title': 'Self care (n=422) Not able to carry out', 'categories': [{'measurements': [{'value': '0.47', 'groupId': 'OG000'}]}]}, {'title': 'Daily activity (n=421) No problem', 'categories': [{'measurements': [{'value': '61.76', 'groupId': 'OG000'}]}]}, {'title': 'Daily activity (n=421) Some problem', 'categories': [{'measurements': [{'value': '37.29', 'groupId': 'OG000'}]}]}, {'title': 'Daily activity (n=421) Not able to carry out', 'categories': [{'measurements': [{'value': '0.95', 'groupId': 'OG000'}]}]}, {'title': 'Pain/Discomfort (n=421) Not present', 'categories': [{'measurements': [{'value': '23.04', 'groupId': 'OG000'}]}]}, {'title': 'Pain/Discomfort (n=421) Moderate', 'categories': [{'measurements': [{'value': '73.63', 'groupId': 'OG000'}]}]}, {'title': 'Pain/Discomfort (n=421) Extreme', 'categories': [{'measurements': [{'value': '3.33', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety/Depressed (n=422) Not present', 'categories': [{'measurements': [{'value': '61.37', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety/Depressed (n=422) Moderate', 'categories': [{'measurements': [{'value': '36.97', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety/Depressed (n=422) Extreme', 'categories': [{'measurements': [{'value': '1.66', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '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", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib', 'description': 'Etoricoxib 60 mg q.d.'}], 'classes': [{'title': 'BPI Worst pain (n=418)', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'BPI Least pain (n=417)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'BPI Average pain (n=419)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'BPI Pain right now (n=416)', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'BPI Interference on general activities (n=419)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'BPI Interference on Mood (n=419)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'BPI Interference on Walking (n=419)', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'BPI Interference on Normal work (n=419)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'BPI Interference on Relations (n=418)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'BPI Interference on Sleep (n=419)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'BPI Interference on Enjoyment of life(n=419)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 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).', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with both baseline and week 4 follow up data were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib', 'description': 'Etoricoxib 60 mg q.d.'}], 'classes': [{'title': 'Effectiveness ((n=418)', 'categories': [{'measurements': [{'value': '2.8', 'spread': '17.0', 'groupId': 'OG000'}]}]}, {'title': 'Side Effect (n=22)', 'categories': [{'measurements': [{'value': '-3.8', 'spread': '16.4', 'groupId': 'OG000'}]}]}, {'title': 'Convenience (n=418)', 'categories': [{'measurements': [{'value': '0.9', 'spread': '10.8', 'groupId': 'OG000'}]}]}, {'title': 'Overall (n=419)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '20.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 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.", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '22 patients who reported side effects at baseline and week 4 were included in "side effect" evaluation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib', 'description': 'Etoricoxib 60 mg q.d.'}], 'classes': [{'title': 'Days Missed From Work (n=138)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Days Missed From Housekeeping Work (n=411)', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '6.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with both baseline and week 4 data were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib 60 mg q.d.'}], 'classes': [{'title': 'SF36 Physical Functioning (n=418)', 'categories': [{'measurements': [{'value': '5.2', 'spread': '19.9', 'groupId': 'OG000'}]}]}, {'title': 'SF36 Role Limiting Due to Physical Problem (n=418)', 'categories': [{'measurements': [{'value': '17.6', 'spread': '49.3', 'groupId': 'OG000'}]}]}, {'title': 'SF36 Bodily Pain (n=418)', 'categories': [{'measurements': [{'value': '10.6', 'spread': '17.7', 'groupId': 'OG000'}]}]}, {'title': 'SF36 General Health (n=419)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '16.2', 'groupId': 'OG000'}]}]}, {'title': 'SF36 Vitality (n=417)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '15.1', 'groupId': 'OG000'}]}]}, {'title': 'SF36 Social Functioning (n=419)', 'categories': [{'measurements': [{'value': '8.7', 'spread': '20.3', 'groupId': 'OG000'}]}]}, {'title': 'SF36 Role Limiting Due to Emotional Problem(n=418)', 'categories': [{'measurements': [{'value': '14.0', 'spread': '50.4', 'groupId': 'OG000'}]}]}, {'title': 'SF36 Mental Health (n=417)', 'categories': [{'measurements': [{'value': '4.4', 'spread': '14.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 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)', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etoricoxib', 'description': 'Etoricoxib 60 mg once a day (q.d.)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '500'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '419'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Etoricoxib', 'description': 'Etoricoxib 60 mg once a day (q.d.)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.6', 'spread': '10.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '365', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '135', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Patient-SF36 (Short form 36) domain scores', 'classes': [{'title': 'SF-36 Physical functional', 'categories': [{'measurements': [{'value': '45.1', 'spread': '51.3', 'groupId': 'BG000'}]}]}, {'title': 'SF-36 Role limitation due to physical problem', 'categories': [{'measurements': [{'value': '24.0', 'spread': '42.5', 'groupId': 'BG000'}]}]}, {'title': 'SF-36 Bodily pain', 'categories': [{'measurements': [{'value': '52.4', 'spread': '63.9', 'groupId': 'BG000'}]}]}, {'title': 'SF-36 General health', 'categories': [{'measurements': [{'value': '52.7', 'spread': '54.5', 'groupId': 'BG000'}]}]}, {'title': 'SF-36 Vitality', 'categories': [{'measurements': [{'value': '55.9', 'spread': '57.6', 'groupId': 'BG000'}]}]}, {'title': 'SF-36 Social functioning', 'categories': [{'measurements': [{'value': '69.0', 'spread': '78.3', 'groupId': 'BG000'}]}]}, {'title': 'SF-36 Role limitation due to emotional problem', 'categories': [{'measurements': [{'value': '41.3', 'spread': '56.6', 'groupId': 'BG000'}]}]}, {'title': 'SF-36 Mental health', 'categories': [{'measurements': [{'value': '61.7', 'spread': '66.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '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).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'TSQM (Treatment Satisfaction Questionnaire for Medication )domain scores', 'classes': [{'title': 'TSQM - Effectiveness', 'categories': [{'measurements': [{'value': '52.1', 'spread': '55.6', 'groupId': 'BG000'}]}]}, {'title': 'TSQM - Side effect', 'categories': [{'measurements': [{'value': '56.9', 'spread': '55.7', 'groupId': 'BG000'}]}]}, {'title': 'TSQM - Convenience', 'categories': [{'measurements': [{'value': '68.0', 'spread': '68.8', 'groupId': 'BG000'}]}]}, {'title': 'TSQM - Overall satisfaction', 'categories': [{'measurements': [{'value': '44.1', 'spread': '45.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', '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.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'The mean of patient BPI (Brief Pain Inventory) scores', 'classes': [{'title': 'BPI -Worst pain', 'categories': [{'measurements': [{'value': '6.4', 'spread': '4.9', 'groupId': 'BG000'}]}]}, {'title': 'BPI -Least pain', 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.5', 'groupId': 'BG000'}]}]}, {'title': 'BPI-Average pain', 'categories': [{'measurements': [{'value': '4.9', 'spread': '3.8', 'groupId': 'BG000'}]}]}, {'title': 'BPI -Pain right now', 'categories': [{'measurements': [{'value': '4.4', 'spread': '3.1', 'groupId': 'BG000'}]}]}, {'title': 'BPI -Interference on general activities', 'categories': [{'measurements': [{'value': '2.9', 'spread': '2.1', 'groupId': 'BG000'}]}]}, {'title': 'BPI - Mood', 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.2', 'groupId': 'BG000'}]}]}, {'title': 'BPI -Walking', 'categories': [{'measurements': [{'value': '4.3', 'spread': '2.9', 'groupId': 'BG000'}]}]}, {'title': 'BPI - Normal work', 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.9', 'groupId': 'BG000'}]}]}, {'title': 'BPI- Relations with other people', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.9', 'groupId': 'BG000'}]}]}, {'title': 'BPI - Sleep', 'categories': [{'measurements': [{'value': '3.3', 'spread': '2.3', 'groupId': 'BG000'}]}]}, {'title': 'BPI - Enjoyment of life', 'categories': [{'measurements': [{'value': '3.0', 'spread': '2.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '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).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'The mean of patient WOMAC ( Western Ontario and McMaster Universities Osteoarthritis Index) subscale', 'classes': [{'title': 'WOMAC Pain subscale', 'categories': [{'measurements': [{'value': '38.5', 'spread': '22.9', 'groupId': 'BG000'}]}]}, {'title': 'WOMAC Stiffness subscale', 'categories': [{'measurements': [{'value': '36.3', 'spread': '26.9', 'groupId': 'BG000'}]}]}, {'title': 'WOMAC Physical Function subscale', 'categories': [{'measurements': [{'value': '38.0', 'spread': '24.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2008-09-22', 'resultsFirstSubmitDate': '2010-01-04', 'studyFirstSubmitQcDate': '2008-09-22', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-04-20', 'studyFirstPostDateStruct': {'date': '2008-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': 'Baseline and end of 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")'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4', 'timeFrame': 'Baseline and 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.'}, {'measure': "Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)", 'timeFrame': 'Baseline', '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.'}, {'measure': "Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART", 'timeFrame': 'Week 4', '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.'}, {'measure': 'Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline', 'timeFrame': '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."}, {'measure': 'Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4', 'timeFrame': '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"}, {'measure': 'Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4', 'timeFrame': 'Baseline and 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).'}, {'measure': 'Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at Week 4', 'timeFrame': 'Baseline and 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."}, {'measure': 'Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4', 'timeFrame': 'Baseline and Week 4'}, {'measure': 'Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4', 'timeFrame': 'Baseline and 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)'}]}, 'conditionsModule': {'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '20536599', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must Be Over 20 Years Of Age, Regardless Of Sex\n* Must Have A Diagnosis Of OA That Requiring Treatment\n* 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)\n* Excluding Osteoarthritis, The Patient Is Judged To Be In Otherwise General Good Health Based On Medical History, Physical Examination, And Routine Laboratory Tests\n* Must Agree To Participate Voluntarily In The Study\n* Must Have The Capacity To Understand And Answer The Questionnaires Used In The Study\n* Must Agree To Return For A Follow-Up Visit With The Treating Physician Four Weeks After The Initiation Of Treatment With Etoricoxib\n* Patient Is Willing To Sign Informed Consent Form\n\nExclusion Criteria:\n\n* Under 20 Years Of Age\n* Severe Hepatic Insufficiency (Child-Pugh Score \\> 9)\n* Advanced Renal Insufficiency (Creatinine Clearance \\< 30 Ml/Min)\n* Any Contraindication Or Warning Or Precaution As Mentioned In The Approved Study Drug Package Insert\n* Gi Ulcer With Active Bleeding Present At Study Enrollment\n* Patient Has A Recent History Of Stroke, Myocardial Infarction Or Transient Ischemic Attack (Within The Previous 2 Years)'}, 'identificationModule': {'nctId': 'NCT00757627', 'briefTitle': 'Patient-Reported Effectiveness and Safety of Etoricoxib in Osteoarthritis (OA)(0663-113)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'Patient-reported Outcomes With Etoricoxib in Real Life', 'orgStudyIdInfo': {'id': '0663-113'}, 'secondaryIdInfos': [{'id': 'MK0663-113'}, {'id': '2008_029'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Etoricoxib', 'interventionNames': ['Drug: etoricoxib']}], 'interventions': [{'name': 'etoricoxib', 'type': 'DRUG', 'otherNames': ['Arcoxia'], 'description': 'etoricoxib 60 mg QD for 4 weeks.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}