Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-02-24 @ 2:31 PM
Study NCT ID:
NCT01430559
Status:
COMPLETED
Last Update Posted:
2020-12-31
First Post:
2011-09-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077239', 'term': 'Meloxicam'}], 'ancestors': [{'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.', 'otherNumAtRisk': 143, 'otherNumAffected': 0, 'seriousNumAtRisk': 143, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Meloxicam 15 mg', 'description': 'Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.', 'otherNumAtRisk': 144, 'otherNumAffected': 0, 'seriousNumAtRisk': 144, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'OA Participants Not Randomized', 'description': 'OA participants in VAS who were not randomized to placebo or meloxicam treatment.', 'otherNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'OA Participants Randomized But Not Treated', 'description': 'OA participants who were randomized but did not receive actual placebo or meloxicam treatment.', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Healthy Participants', 'description': 'Healthy participants who were included in validation part of the study.', 'otherNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Red blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 1 by Using a Paper Worksheet and a Personalized Electronic LogPad System (E-diary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OA Participants', 'description': 'Participants with OA who responded to the WOMAC questionnaire.'}, {'id': 'OG001', 'title': 'Healthy Participants', 'description': 'Healthy participants who responded to the WOMAC questionnaire.'}], 'classes': [{'title': 'Pain subscale (paper worksheet)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.47', 'groupId': 'OG000'}]}]}, {'title': 'Stiffness subscale (paper worksheet)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '1.94', 'groupId': 'OG000'}]}]}, {'title': 'Physical function subscale (paper worksheet)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.56', 'groupId': 'OG000'}]}]}, {'title': 'Total (paper worksheet)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '135.9', 'spread': '35.59', 'groupId': 'OG000'}]}]}, {'title': 'Pain subscale (e-dary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Stiffness subscale (e-diary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Physical function subscale (e-diary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Total (e-diary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '136.0', 'spread': '35.92', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '3.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening 1 (Visit 1: Days -21 to -14)', 'description': 'The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Validation Analysis Set (VAS) - all OA participants who were non-screen failure at Visit 1 (Screening 1) and returned for Visit 2 (Screening 2); and all enrolled healthy participants. Here, n=number of evaluable participants for each specific category.'}, {'type': 'PRIMARY', 'title': 'WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OA Participants', 'description': 'Participants with OA who responded to the WOMAC questionnaire.'}], 'classes': [{'title': 'Pain subscale score', 'categories': [{'measurements': [{'value': '5.6', 'spread': '1.46', 'groupId': 'OG000'}]}]}, {'title': 'Stiffness subscale score', 'categories': [{'measurements': [{'value': '5.4', 'spread': '1.76', 'groupId': 'OG000'}]}]}, {'title': 'Physical function subscale score', 'categories': [{'measurements': [{'value': '5.8', 'spread': '1.52', 'groupId': 'OG000'}]}]}, {'title': 'Total score', 'categories': [{'measurements': [{'value': '136.6', 'spread': '35.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening 2 (Visit 2: Days -14 to -10)', 'description': 'The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'VAS: all OA participants who were non-screen failure at Visit 1 (Screening 1) and returned for Visit 2 (Screening 2).'}, {'type': 'PRIMARY', 'title': 'WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.'}, {'id': 'OG001', 'title': 'Meloxicam 15 mg', 'description': 'Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.'}], 'classes': [{'title': 'Pain subscale score', 'categories': [{'measurements': [{'value': '6.0', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': 'Stiffness subscale score', 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '1.65', 'groupId': 'OG001'}]}]}, {'title': 'Physical function subscale score', 'categories': [{'measurements': [{'value': '6.1', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '1.22', 'groupId': 'OG001'}]}]}, {'title': 'Total score', 'categories': [{'measurements': [{'value': '145.0', 'spread': '31.05', 'groupId': 'OG000'}, {'value': '144.8', 'spread': '29.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1)', 'description': 'The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication, number of participants analyzed=number of participants evaluable for the outcome measure.'}, {'type': 'PRIMARY', 'title': 'WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.'}, {'id': 'OG001', 'title': 'Meloxicam 15 mg', 'description': 'Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.'}], 'classes': [{'title': 'Pain subscale score', 'categories': [{'measurements': [{'value': '4.4', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.90', 'groupId': 'OG001'}]}]}, {'title': 'Stiffness subscale score', 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.96', 'groupId': 'OG001'}]}]}, {'title': 'Physical function subscale score', 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.87', 'groupId': 'OG001'}]}]}, {'title': 'Total score', 'categories': [{'measurements': [{'value': '106.6', 'spread': '49.70', 'groupId': 'OG000'}, {'value': '88.7', 'spread': '44.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 8 (Week 12)', 'description': 'The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication, number of participants analyzed=number of participants evaluable for the outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in WOMAC Pain Subscale Scores at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.'}, {'id': 'OG001', 'title': 'Meloxicam 15 mg', 'description': 'Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.24', 'groupId': 'OG000', 'lowerLimit': '-1.71', 'upperLimit': '-0.77'}, {'value': '-2.06', 'groupId': 'OG001', 'lowerLimit': '-2.53', 'upperLimit': '-1.58'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.82', 'ciLowerLimit': '-1.20', 'ciUpperLimit': '-0.43', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from analysis of covariance (ANCOVA, repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication using Baseline Observation Carried Forward (BOCF) imputation method, number of participants analyzed=number of participants evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.'}, {'id': 'OG001', 'title': 'Meloxicam 15 mg', 'description': 'Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.'}], 'classes': [{'title': 'Pain subscale (Week 2)', 'categories': [{'measurements': [{'value': '-0.76', 'groupId': 'OG000', 'lowerLimit': '-1.15', 'upperLimit': '-0.36'}, {'value': '-1.12', 'groupId': 'OG001', 'lowerLimit': '-1.52', 'upperLimit': '-0.73'}]}]}, {'title': 'Pain subscale (Week 4)', 'categories': [{'measurements': [{'value': '-1.18', 'groupId': 'OG000', 'lowerLimit': '-1.60', 'upperLimit': '-0.76'}, {'value': '-1.53', 'groupId': 'OG001', 'lowerLimit': '-1.95', 'upperLimit': '-1.11'}]}]}, {'title': 'Pain subscale (Week 8)', 'categories': [{'measurements': [{'value': '-1.31', 'groupId': 'OG000', 'lowerLimit': '-1.74', 'upperLimit': '-0.87'}, {'value': '-1.82', 'groupId': 'OG001', 'lowerLimit': '-2.26', 'upperLimit': '-1.39'}]}]}, {'title': 'Pain subscale (Week 12)', 'categories': [{'measurements': [{'value': '-1.24', 'groupId': 'OG000', 'lowerLimit': '-1.71', 'upperLimit': '-0.77'}, {'value': '-2.06', 'groupId': 'OG001', 'lowerLimit': '-2.53', 'upperLimit': '-1.58'}]}]}, {'title': 'Stiffness subscale (Week 2)', 'categories': [{'measurements': [{'value': '-0.78', 'groupId': 'OG000', 'lowerLimit': '-1.16', 'upperLimit': '-0.39'}, {'value': '-1.11', 'groupId': 'OG001', 'lowerLimit': '-1.49', 'upperLimit': '-0.72'}]}]}, {'title': 'Stiffness subscale (Week 4)', 'categories': [{'measurements': [{'value': '-1.14', 'groupId': 'OG000', 'lowerLimit': '-1.58', 'upperLimit': '-0.71'}, {'value': '-1.34', 'groupId': 'OG001', 'lowerLimit': '-1.78', 'upperLimit': '-0.90'}]}]}, {'title': 'Stiffness subscale (Week 8)', 'categories': [{'measurements': [{'value': '-1.23', 'groupId': 'OG000', 'lowerLimit': '-1.66', 'upperLimit': '-0.79'}, {'value': '-1.70', 'groupId': 'OG001', 'lowerLimit': '-2.14', 'upperLimit': '-1.25'}]}]}, {'title': 'Stiffness subscale (Week 12)', 'categories': [{'measurements': [{'value': '-1.20', 'groupId': 'OG000', 'lowerLimit': '-1.67', 'upperLimit': '-0.72'}, {'value': '-1.86', 'groupId': 'OG001', 'lowerLimit': '-2.34', 'upperLimit': '-1.39'}]}]}, {'title': 'Physical function subscale (Week 2)', 'categories': [{'measurements': [{'value': '-0.77', 'groupId': 'OG000', 'lowerLimit': '-1.19', 'upperLimit': '-0.36'}, {'value': '-1.21', 'groupId': 'OG001', 'lowerLimit': '-1.63', 'upperLimit': '-0.80'}]}]}, {'title': 'Physical function subscale (Week 4)', 'categories': [{'measurements': [{'value': '-1.18', 'groupId': 'OG000', 'lowerLimit': '-1.62', 'upperLimit': '-0.75'}, {'value': '-1.53', 'groupId': 'OG001', 'lowerLimit': '-1.96', 'upperLimit': '-1.09'}]}]}, {'title': 'Physical function subscale (Week 8)', 'categories': [{'measurements': [{'value': '-1.31', 'groupId': 'OG000', 'lowerLimit': '-1.74', 'upperLimit': '-0.88'}, {'value': '-1.82', 'groupId': 'OG001', 'lowerLimit': '-2.26', 'upperLimit': '-1.38'}]}]}, {'title': 'Physical function subscale (Week 12)', 'categories': [{'measurements': [{'value': '-1.25', 'groupId': 'OG000', 'lowerLimit': '-1.73', 'upperLimit': '-0.77'}, {'value': '-2.06', 'groupId': 'OG001', 'lowerLimit': '-2.54', 'upperLimit': '-1.58'}]}]}, {'title': 'Average score (Week 2)', 'categories': [{'measurements': [{'value': '-0.77', 'groupId': 'OG000', 'lowerLimit': '-1.15', 'upperLimit': '-0.39'}, {'value': '-1.15', 'groupId': 'OG001', 'lowerLimit': '-1.54', 'upperLimit': '-0.77'}]}]}, {'title': 'Average score (Week 4)', 'categories': [{'measurements': [{'value': '-1.17', 'groupId': 'OG000', 'lowerLimit': '-1.60', 'upperLimit': '-0.75'}, {'value': '-1.47', 'groupId': 'OG001', 'lowerLimit': '-1.90', 'upperLimit': '-1.04'}]}]}, {'title': 'Average score (Week 8)', 'categories': [{'measurements': [{'value': '-1.29', 'groupId': 'OG000', 'lowerLimit': '-1.71', 'upperLimit': '-0.86'}, {'value': '-1.78', 'groupId': 'OG001', 'lowerLimit': '-2.22', 'upperLimit': '-1.35'}]}]}, {'title': 'Average score (Week 12)', 'categories': [{'measurements': [{'value': '-1.23', 'groupId': 'OG000', 'lowerLimit': '-1.70', 'upperLimit': '-0.76'}, {'value': '-2.00', 'groupId': 'OG001', 'lowerLimit': '-2.47', 'upperLimit': '-1.52'}]}]}], 'analyses': [{'pValue': '0.0103', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '-0.09', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Pain subscale (Week 2)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0295', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '-0.04', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'groupDescription': 'Pain subscale (Week 4)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0041', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '-0.17', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'groupDescription': 'Pain subscale (Week 8)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.82', 'ciLowerLimit': '-1.20', 'ciUpperLimit': '-0.43', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'groupDescription': 'Pain subscale (Week 12)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0369', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '-0.02', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'groupDescription': 'Stiffness subscale (Week 2)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2642', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.15', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'groupDescription': 'Stiffness subscale (Week 4)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0140', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '-0.10', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'groupDescription': 'Stiffness subscale (Week 8)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.67', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '-0.28', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'groupDescription': 'Stiffness subscale (Week 12)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '-0.17', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Physical function subscale (Week 2)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0328', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '-0.03', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'groupDescription': 'Physical function subscale (Week 4)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '-0.16', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'groupDescription': 'Physical function subscale (Week 8)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.81', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '-0.43', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'groupDescription': 'Physical function subscale (Week 12)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0051', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '-0.12', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'Average score (Week 2)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0593', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '0.01', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'groupDescription': 'Average score (Week 4)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0046', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '-0.16', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'groupDescription': 'Average score (Week 8)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.76', 'ciLowerLimit': '-1.14', 'ciUpperLimit': '-0.39', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'groupDescription': 'Average score (Week 12)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'description': 'The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. Change from baseline was calculated for each WOMAC subscale (pain, stiffness, physical function) and WOMAC average score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.'}, {'id': 'OG001', 'title': 'Meloxicam 15 mg', 'description': 'Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.'}], 'classes': [{'title': 'Walking on flat surface (Week 2)', 'categories': [{'measurements': [{'value': '-0.51', 'groupId': 'OG000', 'lowerLimit': '-0.92', 'upperLimit': '-0.10'}, {'value': '-1.13', 'groupId': 'OG001', 'lowerLimit': '-1.54', 'upperLimit': '-0.71'}]}]}, {'title': 'Walking on flat surface (Week 4)', 'categories': [{'measurements': [{'value': '-1.04', 'groupId': 'OG000', 'lowerLimit': '-1.50', 'upperLimit': '-0.59'}, {'value': '-1.61', 'groupId': 'OG001', 'lowerLimit': '-2.07', 'upperLimit': '-1.15'}]}]}, {'title': 'Walking on flat surface (Week 8)', 'categories': [{'measurements': [{'value': '-1.17', 'groupId': 'OG000', 'lowerLimit': '-1.63', 'upperLimit': '-0.71'}, {'value': '-1.87', 'groupId': 'OG001', 'lowerLimit': '-2.33', 'upperLimit': '-1.41'}]}]}, {'title': 'Walking on flat surface (Week 12)', 'categories': [{'measurements': [{'value': '-1.05', 'groupId': 'OG000', 'lowerLimit': '-1.53', 'upperLimit': '-0.56'}, {'value': '-1.97', 'groupId': 'OG001', 'lowerLimit': '-2.46', 'upperLimit': '-1.48'}]}]}, {'title': 'Going up or down stairs (Week 2)', 'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'OG000', 'lowerLimit': '-1.40', 'upperLimit': '-0.60'}, {'value': '-1.35', 'groupId': 'OG001', 'lowerLimit': '-1.75', 'upperLimit': '-0.94'}]}]}, {'title': 'Going up or down stairs (Week 4)', 'categories': [{'measurements': [{'value': '-1.34', 'groupId': 'OG000', 'lowerLimit': '-1.76', 'upperLimit': '-0.93'}, {'value': '-1.74', 'groupId': 'OG001', 'lowerLimit': '-2.16', 'upperLimit': '-1.32'}]}]}, {'title': 'Going up or down stairs (Week 8)', 'categories': [{'measurements': [{'value': '-1.53', 'groupId': 'OG000', 'lowerLimit': '-2.00', 'upperLimit': '-1.07'}, {'value': '-2.09', 'groupId': 'OG001', 'lowerLimit': '-2.55', 'upperLimit': '-1.62'}]}]}, {'title': 'Going up or down stairs (Week 12)', 'categories': [{'measurements': [{'value': '-1.34', 'groupId': 'OG000', 'lowerLimit': '-1.83', 'upperLimit': '-0.86'}, {'value': '-2.43', 'groupId': 'OG001', 'lowerLimit': '-2.91', 'upperLimit': '-1.94'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '-0.30', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'groupDescription': 'Walking on flat surface (Week 2)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '-0.22', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'groupDescription': 'Walking on flat surface (Week 4)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '-0.32', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'groupDescription': 'Walking on flat surface (Week 8)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.93', 'ciLowerLimit': '-1.34', 'ciUpperLimit': '-0.51', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'groupDescription': 'Walking on flat surface (Week 12)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0363', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '-0.02', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'groupDescription': 'Going up or down stairs (Week 2)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0311', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '-0.04', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'groupDescription': 'Going up or down stairs (Week 4)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0057', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '-0.16', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'groupDescription': 'Going up or down stairs (Week 8)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.08', 'ciLowerLimit': '-1.52', 'ciUpperLimit': '-0.64', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'groupDescription': 'Going up or down stairs (Week 12)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'description': 'WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. Change from baseline in two of the WOMAC pain subscale items: pain when walking on a flat surface, and pain when going up or down stairs were calculated.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.'}, {'id': 'OG001', 'title': 'Meloxicam 15 mg', 'description': 'Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.'}], 'classes': [{'title': '>0% reduction', 'categories': [{'measurements': [{'value': '53.1', 'groupId': 'OG000'}, {'value': '75.7', 'groupId': 'OG001'}]}]}, {'title': 'Greater than or equal to (>=) 10% reduction', 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000'}, {'value': '67.4', 'groupId': 'OG001'}]}]}, {'title': '>=20% reduction', 'categories': [{'measurements': [{'value': '37.1', 'groupId': 'OG000'}, {'value': '58.3', 'groupId': 'OG001'}]}]}, {'title': '>=30% reduction', 'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000'}, {'value': '49.3', 'groupId': 'OG001'}]}]}, {'title': '>=40% reduction', 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000'}, {'value': '43.8', 'groupId': 'OG001'}]}]}, {'title': '>=50% reduction', 'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000'}, {'value': '34.0', 'groupId': 'OG001'}]}]}, {'title': '>=60% reduction', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}, {'value': '24.3', 'groupId': 'OG001'}]}]}, {'title': '>=70% reduction', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}, {'title': '>=80% reduction', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}, {'title': '>=90% reduction', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': 'WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions. WOMAC pain subscale response rates at Week 12 were shown for the reductions from Baseline of greater than (\\>) 0%, 10% to 90% (in steps of 10%).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.'}, {'id': 'OG001', 'title': 'Meloxicam 15 mg', 'description': 'Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.'}], 'classes': [{'title': '>=30% reduction (Week 2)', 'categories': [{'measurements': [{'value': '17.48', 'groupId': 'OG000'}, {'value': '22.92', 'groupId': 'OG001'}]}]}, {'title': '>=30% reduction (Week 4)', 'categories': [{'measurements': [{'value': '30.07', 'groupId': 'OG000'}, {'value': '36.81', 'groupId': 'OG001'}]}]}, {'title': '>=30% reduction (Week 8)', 'categories': [{'measurements': [{'value': '34.97', 'groupId': 'OG000'}, {'value': '45.14', 'groupId': 'OG001'}]}]}, {'title': '>=30% reduction (Week 12)', 'categories': [{'measurements': [{'value': '29.37', 'groupId': 'OG000'}, {'value': '49.31', 'groupId': 'OG001'}]}]}, {'title': '>=50% reduction (Week 2)', 'categories': [{'measurements': [{'value': '4.90', 'groupId': 'OG000'}, {'value': '9.03', 'groupId': 'OG001'}]}]}, {'title': '>=50% reduction (Week 4)', 'categories': [{'measurements': [{'value': '9.09', 'groupId': 'OG000'}, {'value': '14.58', 'groupId': 'OG001'}]}]}, {'title': '>=50% reduction (Week 8)', 'categories': [{'measurements': [{'value': '13.29', 'groupId': 'OG000'}, {'value': '24.31', 'groupId': 'OG001'}]}]}, {'title': '>=50% reduction (Week 12)', 'categories': [{'measurements': [{'value': '16.08', 'groupId': 'OG000'}, {'value': '34.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2373', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.42', 'ciLowerLimit': '0.79', 'ciUpperLimit': '2.55', 'pValueComment': 'P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.', 'groupDescription': '\\>=30% reduction (Week 2)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2069', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '0.84', 'ciUpperLimit': '2.26', 'pValueComment': 'P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.', 'groupDescription': '\\>=30% reduction (Week 4)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0680', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.56', 'ciLowerLimit': '0.97', 'ciUpperLimit': '2.53', 'pValueComment': 'P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.', 'groupDescription': '\\>=30% reduction (Week 8)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.41', 'ciLowerLimit': '1.47', 'ciUpperLimit': '3.94', 'pValueComment': 'P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.', 'groupDescription': '\\>=30% reduction (Week 12)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1736', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.94', 'ciLowerLimit': '0.75', 'ciUpperLimit': '5.01', 'pValueComment': 'P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.', 'groupDescription': '\\>=50% reduction (Week 2)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1496', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.72', 'ciLowerLimit': '0.82', 'ciUpperLimit': '3.59', 'pValueComment': 'P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.', 'groupDescription': '\\>=50% reduction (Week 4)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0171', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.12', 'ciLowerLimit': '1.14', 'ciUpperLimit': '3.93', 'pValueComment': 'P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.', 'groupDescription': '\\>=50% reduction (Week 8)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.77', 'ciLowerLimit': '1.57', 'ciUpperLimit': '4.89', 'pValueComment': 'P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.', 'groupDescription': '\\>=50% reduction (Week 12)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'description': 'WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure, including the 9 participants (4 placebo, 5 meloxicam) who had missing baseline WOMAC data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.'}, {'id': 'OG001', 'title': 'Meloxicam 15 mg', 'description': 'Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.27', 'groupId': 'OG000', 'lowerLimit': '-0.39', 'upperLimit': '-0.15'}, {'value': '-0.45', 'groupId': 'OG001', 'lowerLimit': '-0.57', 'upperLimit': '-0.33'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.37', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '-0.23'}, {'value': '-0.53', 'groupId': 'OG001', 'lowerLimit': '-0.66', 'upperLimit': '-0.39'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.34', 'groupId': 'OG000', 'lowerLimit': '-0.46', 'upperLimit': '-0.23'}, {'value': '-0.52', 'groupId': 'OG001', 'lowerLimit': '-0.64', 'upperLimit': '-0.40'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.43', 'groupId': 'OG000', 'lowerLimit': '-0.58', 'upperLimit': '-0.28'}, {'value': '-0.62', 'groupId': 'OG001', 'lowerLimit': '-0.78', 'upperLimit': '-0.47'}]}]}], 'analyses': [{'pValue': '0.0027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '-0.07', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0308', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '-0.01', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.07', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0060', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '-0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'nonInferiorityComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.'}, {'pValue': '0.0076', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '-0.05', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.07', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'description': 'PGAO questionnaire ("Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?") was comprised of 5 scores with 1=very good to 5=very poor, where higher grades indicated more effect of osteoarthritis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.'}, {'id': 'OG001', 'title': 'Meloxicam 15 mg', 'description': 'Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '2.80', 'groupId': 'OG000'}, {'value': '4.86', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '6.29', 'groupId': 'OG000'}, {'value': '11.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '5.59', 'groupId': 'OG000'}, {'value': '6.25', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '8.39', 'groupId': 'OG000'}, {'value': '13.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2843', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.13', 'ciLowerLimit': '0.53', 'ciUpperLimit': '8.50', 'pValueComment': 'P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.', 'groupDescription': 'Week 2', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1050', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.05', 'ciLowerLimit': '0.86', 'ciUpperLimit': '4.87', 'pValueComment': 'P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.', 'groupDescription': 'Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7861', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.40', 'ciUpperLimit': '3.32', 'pValueComment': 'P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.', 'groupDescription': 'Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1873', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.71', 'ciLowerLimit': '0.77', 'ciUpperLimit': '3.78', 'pValueComment': 'P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.', 'groupDescription': 'Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'description': 'PGAO questionnaire ("Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?") was comprised of 5 grades with 1=very good to 5=very poor, where higher grades indicated more effect of osteoarthritis. The treatment response of an improvement of \\>=2 points from Baseline in PGAO were summarized.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure, including the 8 participants (3 placebo, 5 meloxicam) who had missing baseline PGAO data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.'}, {'id': 'OG001', 'title': 'Meloxicam 15 mg', 'description': 'Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.'}], 'classes': [{'title': 'General health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.60', 'groupId': 'OG000', 'lowerLimit': '1.93', 'upperLimit': '7.28'}, {'value': '5.98', 'groupId': 'OG001', 'lowerLimit': '3.29', 'upperLimit': '8.67'}]}]}, {'title': 'Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.95', 'groupId': 'OG000', 'lowerLimit': '3.73', 'upperLimit': '10.16'}, {'value': '12.88', 'groupId': 'OG001', 'lowerLimit': '9.65', 'upperLimit': '16.12'}]}]}, {'title': 'Role physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.79', 'groupId': 'OG000', 'lowerLimit': '1.74', 'upperLimit': '9.84'}, {'value': '13.95', 'groupId': 'OG001', 'lowerLimit': '9.89', 'upperLimit': '18.02'}]}]}, {'title': 'Bodily pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.51', 'groupId': 'OG000', 'lowerLimit': '4.44', 'upperLimit': '10.58'}, {'value': '14.87', 'groupId': 'OG001', 'lowerLimit': '11.78', 'upperLimit': '17.96'}]}]}, {'title': 'Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.03', 'groupId': 'OG000', 'lowerLimit': '2.56', 'upperLimit': '7.50'}, {'value': '7.08', 'groupId': 'OG001', 'lowerLimit': '4.61', 'upperLimit': '9.55'}]}]}, {'title': 'Social functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.06', 'groupId': 'OG000', 'lowerLimit': '2.60', 'upperLimit': '9.51'}, {'value': '12.02', 'groupId': 'OG001', 'lowerLimit': '8.55', 'upperLimit': '15.49'}]}]}, {'title': 'Role emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.65', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '9.04'}, {'value': '10.52', 'groupId': 'OG001', 'lowerLimit': '6.11', 'upperLimit': '14.93'}]}]}, {'title': 'Mental health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.50', 'groupId': 'OG000', 'lowerLimit': '2.13', 'upperLimit': '6.87'}, {'value': '5.07', 'groupId': 'OG001', 'lowerLimit': '2.71', 'upperLimit': '7.43'}]}]}, {'title': 'Mental component aggregate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.19', 'groupId': 'OG000', 'lowerLimit': '0.74', 'upperLimit': '3.65'}, {'value': '3.14', 'groupId': 'OG001', 'lowerLimit': '1.67', 'upperLimit': '4.60'}]}]}, {'title': 'Physical component aggregate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.65', 'groupId': 'OG000', 'lowerLimit': '1.36', 'upperLimit': '3.94'}, {'value': '5.21', 'groupId': 'OG001', 'lowerLimit': '3.92', 'upperLimit': '6.51'}]}]}], 'analyses': [{'pValue': '0.3738', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '-1.67', 'ciUpperLimit': '4.42', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.55', 'groupDescription': 'General health', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.94', 'ciLowerLimit': '2.07', 'ciUpperLimit': '9.80', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.96', 'groupDescription': 'Physical functioning', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.16', 'ciLowerLimit': '3.95', 'ciUpperLimit': '12.38', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.14', 'groupDescription': 'Role physical', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.36', 'ciLowerLimit': '4.10', 'ciUpperLimit': '10.63', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.66', 'groupDescription': 'Bodily pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2124', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.05', 'ciLowerLimit': '-1.18', 'ciUpperLimit': '5.27', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.64', 'groupDescription': 'Vitality', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0050', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.96', 'ciLowerLimit': '1.82', 'ciUpperLimit': '10.10', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.10', 'groupDescription': 'Social functioning', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0093', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.87', 'ciLowerLimit': '1.46', 'ciUpperLimit': '10.28', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.24', 'groupDescription': 'Role emotional', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7274', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '-2.66', 'ciUpperLimit': '3.81', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.64', 'groupDescription': 'Mental health', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2819', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '-0.78', 'ciUpperLimit': '2.67', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.88', 'groupDescription': 'Mental component aggregate', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.57', 'ciLowerLimit': '1.27', 'ciUpperLimit': '3.86', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.66', 'groupDescription': 'Physical component aggregate', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The SF-36 is a self-administered questionnaire that measures each of the following 8 health domains: physical functioning, role limitations due to physical problems (role-physical), social functioning, bodily pain, mental health, role limitations due to emotional problems (role-emotional), vitality, and general health perception. There are also 2 component scores derived from the 8 subscale scores: physical component summary (including physical functioning, role-physical, bodily pain and general health) and mental component summary (including vitality, social functioning, role-emotional and mental health). Each SF-36 domain and component summary score ranges from 0 to 100, higher scores reflect better participant health status.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure, n=number of evaluable participants for each specific SF-36 domain.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.'}, {'id': 'OG001', 'title': 'Meloxicam 15 mg', 'description': 'Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.'}], 'classes': [{'title': 'Mobility (decrease by 2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Mobility (decrease by 1)', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Mobility (decrease by 0)', 'categories': [{'measurements': [{'value': '79.7', 'groupId': 'OG000'}, {'value': '66.0', 'groupId': 'OG001'}]}]}, {'title': 'Mobility (decrease by -1)', 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000'}, {'value': '28.5', 'groupId': 'OG001'}]}]}, {'title': 'Mobility (decrease by -2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Self-care (decrease by 2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Self-care (decrease by 1)', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'Self-care (decrease by 0)', 'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000'}, {'value': '55.6', 'groupId': 'OG001'}]}]}, {'title': 'Self-care (decrease by -1)', 'categories': [{'measurements': [{'value': '25.2', 'groupId': 'OG000'}, {'value': '35.4', 'groupId': 'OG001'}]}]}, {'title': 'Self-care (decrease by -2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Usual activities (decrease by 2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Usual activities (decrease by 1)', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Usual activities (decrease by 0)', 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000'}, {'value': '63.2', 'groupId': 'OG001'}]}]}, {'title': 'Usual activities (decrease by -1)', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}, {'value': '29.2', 'groupId': 'OG001'}]}]}, {'title': 'Usual activities (decrease by -2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pain/discomfort (decrease by 2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pain/discomfort (decrease by 1)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Pain/discomfort (decrease by 0)', 'categories': [{'measurements': [{'value': '77.6', 'groupId': 'OG000'}, {'value': '67.4', 'groupId': 'OG001'}]}]}, {'title': 'Pain/discomfort (decrease by -1)', 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Pain/discomfort (decrease by -2)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/depression (decrease by 2)', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/depression (decrease by 1)', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/depression (decrease by 0)', 'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000'}, {'value': '67.4', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/depression (decrease by -1)', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}, {'value': '20.8', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/depression (decrease by -2)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.60', 'ciLowerLimit': '1.45', 'ciUpperLimit': '4.66', 'pValueComment': 'P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.', 'groupDescription': 'Mobility', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1080', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '0.91', 'ciUpperLimit': '2.48', 'pValueComment': 'P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.', 'groupDescription': 'Self-care', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0119', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.06', 'ciLowerLimit': '1.17', 'ciUpperLimit': '3.62', 'pValueComment': 'P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.', 'groupDescription': 'Usual activities', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0887', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '0.93', 'ciUpperLimit': '2.83', 'pValueComment': 'P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.', 'groupDescription': 'Pain/discomfort', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2466', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.37', 'ciLowerLimit': '0.80', 'ciUpperLimit': '2.33', 'pValueComment': 'P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.', 'groupDescription': 'Anxiety/depression', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': 'The EQ-5D is a generic measure of health related quality of life. The EQ-5D has 5 items that assess the level of difficulty (none \\[score of 1\\], some/moderate \\[score of 2\\], extreme \\[score of 3\\]) respondents report for 5 health status domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The change from Baseline (decrease by 2, 1, 0, -1 and -2) at Week 12 in each of the 5 health status domains were summarized.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure, including the 12 participants (5 placebo, 7 meloxicam) who had missing baseline EQ-5D data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weekly Average Pain Score in the Index Knee Using 11-point Numeric Rating Scale (NRS) at Weeks 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.'}, {'id': 'OG001', 'title': 'Meloxicam 15 mg', 'description': 'Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.67', 'groupId': 'OG000', 'lowerLimit': '-1.00', 'upperLimit': '-0.34'}, {'value': '-0.97', 'groupId': 'OG001', 'lowerLimit': '-1.30', 'upperLimit': '-0.64'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-1.11', 'groupId': 'OG000', 'lowerLimit': '-1.51', 'upperLimit': '-0.70'}, {'value': '-1.42', 'groupId': 'OG001', 'lowerLimit': '-1.83', 'upperLimit': '-1.01'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.31', 'groupId': 'OG000', 'lowerLimit': '-1.78', 'upperLimit': '-0.85'}, {'value': '-1.76', 'groupId': 'OG001', 'lowerLimit': '-2.22', 'upperLimit': '-1.29'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-1.43', 'groupId': 'OG000', 'lowerLimit': '-1.94', 'upperLimit': '-0.91'}, {'value': '-2.06', 'groupId': 'OG001', 'lowerLimit': '-2.57', 'upperLimit': '-1.55'}]}]}], 'analyses': [{'pValue': '0.0367', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '-0.02', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0652', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '0.02', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0200', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '-0.07', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-1.02', 'ciUpperLimit': '-0.24', 'pValueComment': 'P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'description': 'Daily average knee pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain. The participants described their pain in the index knee during the past 24 hours by choosing the appropriate number from 0 to 10.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.'}, {'id': 'FG001', 'title': 'Meloxicam 15 mg', 'description': 'Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '147'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '144'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '135'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Entry criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Medication error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Randomized, Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'A total of 24 centers in mainland China recruited study participants, starting from 24 Oct 2011 to 14 Dec 2012.', 'preAssignmentDetails': 'This study comprised of a Screening Period prior to Treatment Period. During Screening, 52 healthy participants and 356 participants with osteoarthritis (OA) were included in validation analysis set (total enrollment=408), 293 out of the 356 OA participants were assigned randomized to treatment, and 6 of these randomized participants did not receive actual treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.'}, {'id': 'BG001', 'title': 'Meloxicam 15 mg', 'description': 'Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '26 to 35 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '36 to 45 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': '46 to 55 years', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': '56 to 65 years', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}, {'title': '66 to 75 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 408}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2013-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-06', 'studyFirstSubmitDate': '2011-09-06', 'resultsFirstSubmitDate': '2020-12-06', 'studyFirstSubmitQcDate': '2011-09-06', 'lastUpdatePostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-06', 'studyFirstPostDateStruct': {'date': '2011-09-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 1 by Using a Paper Worksheet and a Personalized Electronic LogPad System (E-diary)', 'timeFrame': 'Screening 1 (Visit 1: Days -21 to -14)', 'description': 'The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.'}, {'measure': 'WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary', 'timeFrame': 'Screening 2 (Visit 2: Days -14 to -10)', 'description': 'The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.'}, {'measure': 'WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary', 'timeFrame': 'Baseline (Day 1)', 'description': 'The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.'}, {'measure': 'WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary', 'timeFrame': 'Visit 8 (Week 12)', 'description': 'The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.'}, {'measure': 'Change From Baseline in WOMAC Pain Subscale Scores at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'description': 'The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. Change from baseline was calculated for each WOMAC subscale (pain, stiffness, physical function) and WOMAC average score.'}, {'measure': 'Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'description': 'WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. Change from baseline in two of the WOMAC pain subscale items: pain when walking on a flat surface, and pain when going up or down stairs were calculated.'}, {'measure': 'Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions. WOMAC pain subscale response rates at Week 12 were shown for the reductions from Baseline of greater than (\\>) 0%, 10% to 90% (in steps of 10%).'}, {'measure': 'Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'description': 'WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions.'}, {'measure': 'Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'description': 'PGAO questionnaire ("Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?") was comprised of 5 scores with 1=very good to 5=very poor, where higher grades indicated more effect of osteoarthritis.'}, {'measure': 'Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'description': 'PGAO questionnaire ("Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?") was comprised of 5 grades with 1=very good to 5=very poor, where higher grades indicated more effect of osteoarthritis. The treatment response of an improvement of \\>=2 points from Baseline in PGAO were summarized.'}, {'measure': 'Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'The SF-36 is a self-administered questionnaire that measures each of the following 8 health domains: physical functioning, role limitations due to physical problems (role-physical), social functioning, bodily pain, mental health, role limitations due to emotional problems (role-emotional), vitality, and general health perception. There are also 2 component scores derived from the 8 subscale scores: physical component summary (including physical functioning, role-physical, bodily pain and general health) and mental component summary (including vitality, social functioning, role-emotional and mental health). Each SF-36 domain and component summary score ranges from 0 to 100, higher scores reflect better participant health status.'}, {'measure': 'Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'The EQ-5D is a generic measure of health related quality of life. The EQ-5D has 5 items that assess the level of difficulty (none \\[score of 1\\], some/moderate \\[score of 2\\], extreme \\[score of 3\\]) respondents report for 5 health status domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The change from Baseline (decrease by 2, 1, 0, -1 and -2) at Week 12 in each of the 5 health status domains were summarized.'}, {'measure': 'Change From Baseline in Weekly Average Pain Score in the Index Knee Using 11-point Numeric Rating Scale (NRS) at Weeks 2, 4, 8 and 12', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'description': 'Daily average knee pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain. The participants described their pain in the index knee during the past 24 hours by choosing the appropriate number from 0 to 10.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Validation of the WOMAC in Chinese subjects with osteoarthritis of the knee'], 'conditions': ['Osteoarthritis of the Knee']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9001449&StudyName=Effect%20Of%20Meloxicam%20Versus%20Placebo%20In%20Mainland%20Chinese%20Patients%20With%20Osteoarthritis%20Of%20The%20Knee%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is to validate the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) tool in mainland Chinese patients with osteoarthritis of the knee . This study will also evaluate the effects of Mobic versus placebo on reducing the symptoms of osteoarthritis in this population.', 'detailedDescription': 'To validate culturally the WOMAC tool in mainland China and observe the different response of meloxicam and placebo in a patient population with osteoarthritis of the knee'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects are required to meet the following criteria to be eligible for Randomization into this study:\n\n* Male or female Chinese subjects, 18-75 years of age;\n* Subjects must have a diagnosis of OA of the index knee based on American College of Rheumatology criteria with X ray confirmation (a Kellgren Lawrence x ray grade of greater than or equal to 2) (Kellgren J. \\& Lawrence J, 1957)\n* Subjects must have have an NRS and a WOMAC pain sub scale score of 4 at Screening and at Baseline based on four daily diary entries\n\nExclusion Criteria:\n\nSubjects presenting with any of the following will not be included in the study:\n\n* History of other disease that may involve the index (painful) knee including inflammatory joint diseases or have had recent surgical intervention on the knee.\n* Diagnosed as having or has been treated for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication. History of or active gastrointestinal disease (eg, inflammatory bowel disease), a chronic or acute renal or hepatic disorder, or a significant coagulation defect.\n* Signs and symptoms of clinically significant cardiac disease'}, 'identificationModule': {'nctId': 'NCT01430559', 'briefTitle': 'Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP STUDY OF THE EFFECT OF MELOXICAM IN MAINLAND CHINESE SUBJECTS WITH OSTEOARTHRITIS (OA) OF THE KNEE', 'orgStudyIdInfo': {'id': 'A9001449'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Meloxicam', 'interventionNames': ['Drug: Meloxicam']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2 Placebo capsules once a day for 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Meloxicam', 'type': 'DRUG', 'otherNames': ['Mobic'], 'description': '7.5mg x2 once a day for 12 weeks', 'armGroupLabels': ['Meloxicam']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Study subjects will be randomized to two treatment groups: one with Meloxicam 7.5 mgx2 once a day and another one with placebo. The duration of the interventional treatment is 12 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230001', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'Anhui Province Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The Third Affiliated Hospital Of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '515041', 'city': 'Shantou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Shantou Medical Collage', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}, {'zip': '150001', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Rheumatology Department, The first Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Rheumatology Department, The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'QiLu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '252000', 'city': 'Liaocheng', 'state': 'Shandong', 'country': 'China', 'facility': "Liaocheng People's Hospital/Orthopaedics", 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}, {'zip': '266011', 'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'facility': 'Department of Immunology and Rheumatology, Qingdao Municipal Hospital', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'zip': '266011', 'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'facility': 'Department of Immunology and Rheumatology,Qingdao Municipal Hospital', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'zip': '710032', 'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': 'Xijing Hospital, The Fourth Military Medical University', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Department of Orthopedics, West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610044', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Department of Rheumatology and Immunology,West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610072', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Department of Rheumatology and Immunology, Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610072', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Sichuan Provincial People's Hospital, Rheumatology", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '100029', 'city': 'Beijing', 'country': 'China', 'facility': 'China-Japan Friendship Hospital/Rheumatology Department', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100032', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100044', 'city': 'Beijing', 'country': 'China', 'facility': 'Li Zhanguo', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100053', 'city': 'Beijing', 'country': 'China', 'facility': 'Rheumatology and Immunology Department, Xuanwu Hospital Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital, Orthopaedics', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200001', 'city': 'Shanghai', 'country': 'China', 'facility': 'Renji Hospital Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200003', 'city': 'Shanghai', 'country': 'China', 'facility': 'Rheumatology and Immunology Department, Shanghai Changzheng Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'Zhongshan Hospital Fudan University, Rheumatology Department', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '300052', 'city': 'Tianjin', 'country': 'China', 'facility': 'Department of Infectious Diseases & Immunology, Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}