Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-03-02 @ 3:48 PM
Study NCT ID:
NCT00664560
Status:
COMPLETED
Last Update Posted:
2012-02-27
First Post:
2008-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eorlemans@pozen.com', 'phone': '919-913-1030', 'title': 'Sr VP Clinical Research', 'organization': 'POZEN Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'randomization -28 days post last dose', 'eventGroups': [{'id': 'EG000', 'title': '(PN 400 (VIMOVO) Twice Daily)', 'description': 'PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole', 'otherNumAtRisk': 247, 'otherNumAffected': 118, 'seriousNumAtRisk': 247, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': '(Celebrex 200 mg Once Daily)', 'description': 'Celecoxib 200 mg (Celebrex) taken once daily', 'otherNumAtRisk': 243, 'otherNumAffected': 101, 'seriousNumAtRisk': 243, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': '(Placebo Twice Daily)', 'description': 'placebo (sugar pill) dosed twice daily (bid)', 'otherNumAtRisk': 124, 'otherNumAffected': 77, 'seriousNumAtRisk': 124, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hyperchlorhydria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'seriousEvents': [{'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '(PN 400 (VIMOVO) Twice Daily)', 'description': 'PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole'}, {'id': 'OG001', 'title': '(Celebrex 200 mg Once Daily)', 'description': 'Celecoxib 200 mg (Celebrex) taken once daily'}, {'id': 'OG002', 'title': '(Placebo Twice Daily)', 'description': 'placebo (sugar pill) dosed twice daily (bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '-43.4', 'spread': '26.8', 'groupId': 'OG000'}, {'value': '-41.1', 'spread': '26.2', 'groupId': 'OG001'}, {'value': '-34.0', 'spread': '25.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-4.76', 'ciUpperLimit': '4.32', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain at 12 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis Population: Baseline + took \\>= 1 dose + \\>= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward'}, {'type': 'PRIMARY', 'title': 'Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '(PN 400 (VIMOVO) Twice Daily)', 'description': 'PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole'}, {'id': 'OG001', 'title': '(Celebrex 200 mg Once Daily)', 'description': 'Celecoxib 200 mg (Celebrex) taken once daily'}, {'id': 'OG002', 'title': '(Placebo Twice Daily)', 'description': 'placebo (sugar pill) dosed twice daily (bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '-37.5', 'spread': '27.1', 'groupId': 'OG000'}, {'value': '-36.0', 'spread': '26.4', 'groupId': 'OG001'}, {'value': '-28.9', 'spread': '24.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-4.57', 'ciUpperLimit': '4.38', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': '10 mm Non-Inferiority (NI) margin between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain from baseline (in mm).\n\nThe Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis Population: Baseline + took \\>= 1 dose + \\>= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward'}, {'type': 'PRIMARY', 'title': 'Change in Patient Global Assessment (PGA) Subscore From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '(PN 400 (VIMOVO) Twice Daily)', 'description': 'PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole'}, {'id': 'OG001', 'title': '(Celebrex 200 mg Once Daily)', 'description': 'Celecoxib 200 mg (Celebrex) taken once daily'}, {'id': 'OG002', 'title': '(Placebo Twice Daily)', 'description': 'placebo (sugar pill) dosed twice daily (bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '21.5', 'spread': '33.4', 'groupId': 'OG000'}, {'value': '22.4', 'spread': '28.7', 'groupId': 'OG001'}, {'value': '12.4', 'spread': '28.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-5.08', 'ciUpperLimit': '4.14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-Inferiority (NI) margin 10 mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis Population: Baseline + took \\>= 1 dose + \\>= 1 post-baseline PGA efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward'}, {'type': 'SECONDARY', 'title': 'American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '(PN 400 (VIMOVO) Twice Daily)', 'description': 'PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole'}, {'id': 'OG001', 'title': '(Celebrex 200 mg Once Daily)', 'description': 'Celecoxib 200 mg (Celebrex) taken once daily'}, {'id': 'OG002', 'title': '(Placebo Twice Daily)', 'description': 'placebo (sugar pill) dosed twice daily (bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.8', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '-17.7', 'spread': '16.0', 'groupId': 'OG001'}, {'value': '-12.8', 'spread': '13.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 7', 'description': 'Mean change from Baseline scores calculated for each subject through Day 7. Scale 0 through 70, where 0=no pain interference and 70=complete interference.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '(PN 400 (VIMOVO) Twice Daily)', 'description': 'PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole'}, {'id': 'OG001', 'title': '(Celebrex 200 mg Once Daily)', 'description': 'Celecoxib 200 mg (Celebrex) taken once daily'}, {'id': 'OG002', 'title': '(Placebo Twice Daily)', 'description': 'placebo (sugar pill) dosed twice daily (bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '-40.9', 'spread': '26.9', 'groupId': 'OG000'}, {'value': '-39.4', 'spread': '25.4', 'groupId': 'OG001'}, {'value': '-30.7', 'spread': '25.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6', 'description': 'Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain at 6 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '(PN 400 (VIMOVO) Twice Daily)', 'description': 'PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole'}, {'id': 'OG001', 'title': '(Celebrex 200 mg Once Daily)', 'description': 'Celecoxib 200 mg (Celebrex) taken once daily'}, {'id': 'OG002', 'title': '(Placebo Twice Daily)', 'description': 'placebo (sugar pill) dosed twice daily (bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '-35.3', 'spread': '26.9', 'groupId': 'OG000'}, {'value': '-33.9', 'spread': '25.6', 'groupId': 'OG001'}, {'value': '-27.3', 'spread': '26', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6', 'description': 'WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain from baseline (in mm).\n\nThe Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Change in Patient Global Assessment (PGA) Subscore From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '(PN 400 (VIMOVO) Twice Daily)', 'description': 'PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole'}, {'id': 'OG001', 'title': '(Celebrex 200 mg Once Daily)', 'description': 'Celecoxib 200 mg (Celebrex) taken once daily'}, {'id': 'OG002', 'title': '(Placebo Twice Daily)', 'description': 'placebo (sugar pill) dosed twice daily (bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '22.6', 'spread': '31.6', 'groupId': 'OG000'}, {'value': '20.7', 'spread': '28.8', 'groupId': 'OG001'}, {'value': '14.7', 'spread': '29.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6', 'description': 'PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Antacid Tablet Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '(PN 400 (VIMOVO) Twice Daily)', 'description': 'PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole'}, {'id': 'OG001', 'title': '(Celebrex 200 mg Once Daily)', 'description': 'Celecoxib 200 mg (Celebrex) taken once daily'}, {'id': 'OG002', 'title': '(Placebo Twice Daily)', 'description': 'placebo (sugar pill) dosed twice daily (bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '21.6', 'groupId': 'OG001'}, {'value': '15.4', 'spread': '37.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Tablet pill count', 'unitOfMeasure': 'Tablets per subject', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified Severity of Dyspepsia Assessment (mSODA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '(PN 400 (VIMOVO) Twice Daily)', 'description': 'PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole'}, {'id': 'OG001', 'title': '(Celebrex 200 mg Once Daily)', 'description': 'Celecoxib 200 mg (Celebrex) taken once daily'}, {'id': 'OG002', 'title': '(Placebo Twice Daily)', 'description': 'placebo (sugar pill) dosed twice daily (bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.5', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '9.1', 'groupId': 'OG001'}, {'value': '-4.0', 'spread': '9.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Change from Baseline in the Modified Severity of Dyspepsia Assessment (mSODA) average daily pain intensity converted total score at Week 12. The mSODA instruments consists of 6 questions about abdominal discomfort during the past 24 hours, with a converted score of 2 through 47. Lower score equals less pain.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Days With no Heartburn (Heartburn Resolution)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '(PN 400 (VIMOVO) Twice Daily)', 'description': 'PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole'}, {'id': 'OG001', 'title': '(Celebrex 200 mg Once Daily)', 'description': 'Celecoxib 200 mg (Celebrex) taken once daily'}, {'id': 'OG002', 'title': '(Placebo Twice Daily)', 'description': 'placebo (sugar pill) dosed twice daily (bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '83.9', 'spread': '29.8', 'groupId': 'OG000'}, {'value': '75.8', 'spread': '34.1', 'groupId': 'OG001'}, {'value': '68.5', 'spread': '37.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'During 12 weeks, daily heartburn question with ratings none, mild, moderate, or severe. Percent of days with Heartburn resolution (heartburn is none).', 'unitOfMeasure': 'percent days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal (UGI) Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '(PN 400 (VIMOVO) Twice Daily)', 'description': 'PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole'}, {'id': 'OG001', 'title': '(Celebrex 200 mg Once Daily)', 'description': 'Celecoxib 200 mg (Celebrex) taken once daily'}, {'id': 'OG002', 'title': '(Placebo Twice Daily)', 'description': 'placebo (sugar pill) dosed twice daily (bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'daily during 12 weeks', 'description': 'Number of participants reporting pre-specified non-steroidal antiinflammatory drug-associated (NSAID) upper gastrointestinal (UGI) symptoms. Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'The Number of Subjects Who Discontinued From the Study Due to Any Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '(PN 400 (VIMOVO) Twice Daily)', 'description': 'PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole'}, {'id': 'OG001', 'title': '(Celebrex 200 mg Once Daily)', 'description': 'Celecoxib 200 mg (Celebrex) taken once daily'}, {'id': 'OG002', 'title': '(Placebo Twice Daily)', 'description': 'placebo (sugar pill) dosed twice daily (bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'daily during 12 weeks', 'description': 'The number of subjects who discontinued from the study due to any pre-specified non-steroidal antiinflammatory drug (NSAID)-associated upper gastrointestinal (UGI) adverse event (as classified by MedDRA). Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '(PN 400 (VIMOVO) Twice Daily)', 'description': 'PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole'}, {'id': 'FG001', 'title': '(Celebrex 200 mg Once Daily)', 'description': 'Celecoxib 200 mg (Celebrex) taken once daily'}, {'id': 'FG002', 'title': '(Placebo Twice Daily)', 'description': 'placebo (sugar pill) dosed twice daily (bid)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Safety Population', 'groupId': 'FG000', 'numSubjects': '247'}, {'comment': 'Safety Population', 'groupId': 'FG001', 'numSubjects': '243'}, {'comment': 'Safety Population', 'groupId': 'FG002', 'numSubjects': '124'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '208'}, {'groupId': 'FG002', 'numSubjects': '105'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '614', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '(PN 400 (VIMOVO) Twice Daily)', 'description': 'PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole'}, {'id': 'BG001', 'title': '(Celebrex 200 mg Once Daily)', 'description': 'Celecoxib 200 mg (Celebrex) taken once daily'}, {'id': 'BG002', 'title': '(Placebo Twice Daily)', 'description': 'placebo (sugar pill) dosed twice daily (bid)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '61.5', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '61.6', 'spread': '8.2', 'groupId': 'BG002'}, {'value': '61.9', 'spread': '7.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '392', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '222', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 614}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'dispFirstSubmitDate': '2009-12-01', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-20', 'studyFirstSubmitDate': '2008-04-18', 'dispFirstSubmitQcDate': '2009-12-01', 'resultsFirstSubmitDate': '2010-05-27', 'studyFirstSubmitQcDate': '2008-04-22', 'dispFirstPostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-20', 'studyFirstPostDateStruct': {'date': '2008-04-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain at 12 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).'}, {'measure': 'Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline', 'timeFrame': '12 weeks', 'description': 'WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain from baseline (in mm).\n\nThe Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).'}, {'measure': 'Change in Patient Global Assessment (PGA) Subscore From Baseline', 'timeFrame': '12 weeks', 'description': 'PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.'}], 'secondaryOutcomes': [{'measure': 'American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain.', 'timeFrame': 'Baseline and Day 7', 'description': 'Mean change from Baseline scores calculated for each subject through Day 7. Scale 0 through 70, where 0=no pain interference and 70=complete interference.'}, {'measure': 'Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline', 'timeFrame': 'Week 6', 'description': 'Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain at 6 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).'}, {'measure': 'Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline', 'timeFrame': 'Week 6', 'description': 'WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain from baseline (in mm).\n\nThe Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).'}, {'measure': 'Change in Patient Global Assessment (PGA) Subscore From Baseline', 'timeFrame': 'Week 6', 'description': 'PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.'}, {'measure': 'Antacid Tablet Use', 'timeFrame': '12 weeks', 'description': 'Tablet pill count'}, {'measure': 'Modified Severity of Dyspepsia Assessment (mSODA)', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Change from Baseline in the Modified Severity of Dyspepsia Assessment (mSODA) average daily pain intensity converted total score at Week 12. The mSODA instruments consists of 6 questions about abdominal discomfort during the past 24 hours, with a converted score of 2 through 47. Lower score equals less pain.'}, {'measure': 'Percent of Days With no Heartburn (Heartburn Resolution)', 'timeFrame': '12 weeks', 'description': 'During 12 weeks, daily heartburn question with ratings none, mild, moderate, or severe. Percent of days with Heartburn resolution (heartburn is none).'}, {'measure': 'Number of Participants Reporting Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal (UGI) Symptoms', 'timeFrame': 'daily during 12 weeks', 'description': 'Number of participants reporting pre-specified non-steroidal antiinflammatory drug-associated (NSAID) upper gastrointestinal (UGI) symptoms. Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.'}, {'measure': 'The Number of Subjects Who Discontinued From the Study Due to Any Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal Adverse Event', 'timeFrame': 'daily during 12 weeks', 'description': 'The number of subjects who discontinued from the study due to any pre-specified non-steroidal antiinflammatory drug (NSAID)-associated upper gastrointestinal (UGI) adverse event (as classified by MedDRA). Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '26313454', 'type': 'DERIVED', 'citation': 'Holt RJ, Fort JG, Grahn AY, Kent JD, Bello AE. Onset and durability of pain relief in knee osteoarthritis: Pooled results from two placebo trials of naproxen/esomeprazole combination and celecoxib. Phys Sportsmed. 2015 Jul;43(3):200-12. doi: 10.1080/00913847.2015.1074852. Epub 2015 Aug 3.'}, {'pmid': '26235613', 'type': 'DERIVED', 'citation': 'Holt RJ, Fort JG, Grahn AY, Kent JD, Bello AE. Onset and durability of pain relief in knee osteoarthritis: pooled results from two placebo trials of naproxen/esomeprazole combination and celecoxib. Phys Sportsmed. 2015 Aug 3:1-13. Online ahead of print.'}, {'pmid': '21524238', 'type': 'DERIVED', 'citation': 'Hochberg MC, Fort JG, Svensson O, Hwang C, Sostek M. Fixed-dose combination of enteric-coated naproxen and immediate-release esomeprazole has comparable efficacy to celecoxib for knee osteoarthritis: two randomized trials. Curr Med Res Opin. 2011 Jun;27(6):1243-53. doi: 10.1185/03007995.2011.580340. Epub 2011 Apr 28.'}]}, 'descriptionModule': {'briefSummary': 'We will evaluate the efficacy of PN400 and an active comparator in patients that have Osteoarthritis of the knee.', 'detailedDescription': '3-Month study in subjects 50 years and older with osteoarthritis of the knee. Assessments Western Ontario and McMaster Universities (WOMAC) pain and function and patient global assessment scales.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Male or non-pregnant female subjects50 years of age and older with a 6-month history of OA of the knee\n2. Female subjects were eligible for participation in the study if they were of non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or of childbearing potential, had a negative pregnancy test at Screening, and using adequate contraceptive methods.\n3. Subjects were required to have been on a stable dose of NSAIDs, COX-2 inhibitors or other oral analgesic therapy for at least 6 weeks and required to continue treatment for 12 weeks. Current oral analgesic therapy was withdrawn at Screening.\n4. Each subject was required to be able to understand and comply with study procedures required of a subject and was able and willing to provide written informed consent prior to any study procedures being performed.\n5. Subjects were required to agree to keep physical activity at a stable level throughout the study.\n6. Subjects were required to have symptomatic OA of the knee meeting American College of Rheumatology (ACR) criteria for clinical diagnosis of OA.\n7. Subjects were required to have an ACR functional class rating of I, II or III. In addition, subjects meet the requirements for OA flare at the Baseline/ Randomization Visit.\n\nExclusion Criteria\n\n1. Subjects with rheumatoid arthritis or gout/pseudo-gout\n2. Subjects with fibromyalgia syndrome\n3. Acute joint trauma at the index joint within the 3 months prior to screen with active symptoms\n4. Previous (in the past 12 months) or anticipated need for surgical or invasive procedure performed on the index joint during the study\n5. Subject was currently taking or anticipated to take Coumadin®, warfarin, or lithium\n6. History of hypersensitivity to esomeprazole or to another PPI\n7. History of allergic reaction or intolerance to any NSAID (including aspirin) and/or subject had a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps\n8. History of allergic reactions to sulfonamides\n9. Subjects with intra-articular or intramuscular corticosteroids or intra-articular hyaluronic acid injections within 8 weeks prior to randomization\n10. Participation in any study of an investigational treatment in the 4 weeks before Screening\n11. Presence of uncontrolled acute or chronic medical illness, e.g. morbid obesity, GI disorder, diabetes, active GI disease, chronic or acute renal or hepatic disorder, depression and/or infection, etc, that would endanger a subject if the subject were to participate in the study\n12. GI disorder (e.g., severe erosive esophagitis, Zollinger Ellison syndrome) or surgery leading to impaired drug absorption\n13. Peptic ulcer disease within 6 months prior to Screening\n14. Evidence of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in the investigator's opinion would have endangered a subject if the subject were to participate in the study\n15. Schizophrenia or bipolar disorder\n16. Subjects who had started physical therapy on the index joint less than 6 weeks prior to study Screening\n17. Use of any excluded concomitant medication\n18. A recent history (in the past 3 months) suggestive of alcohol or drug abuse or dependence, including overuse/abuse of narcotics for management of pain\n19. Serious blood coagulation disorder including use of systemic anti-coagulants\n20. Screening laboratory value for alanine aminotransferase, aspartate aminotransferase greater than 2 times the upper limit of normal\n21. Estimated creatinine clearance less than 30 ml/min\n22. Other than noted specifically, any Screening laboratory value that was clinically significant in the investigator's opinion and would have endangered a subject if the subjects were to participate in the study\n23. History of malignancy, treated or untreated, within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin\n24. Previous participation in another PN 400 clinical research trial\n25. Subjects who were employees of the research facility or who were in some way under the supervision of the principal investigator for this study"}, 'identificationModule': {'nctId': 'NCT00664560', 'briefTitle': 'Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'POZEN'}, 'officialTitle': 'Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Center Study Evaluating the Efficacy of PN400 (VIMOVO) Twice Daily (Bid) and Celecoxib Once Daily (qd) in Patients With Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': 'PN400-307'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARM 1 PN 400 (VIMOVO)', 'description': 'PN400: 500 mg naproxen/20 mg esomeprazole', 'interventionNames': ['Drug: PN 400 (VIMOVO)', 'Drug: Rescue Antacid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2 (celebrex)', 'description': 'Celecoxib 200 mg', 'interventionNames': ['Drug: celebrex', 'Drug: Rescue Antacid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 3 (placebo)', 'description': 'sugar pill', 'interventionNames': ['Drug: Placebo', 'Drug: Rescue Antacid']}], 'interventions': [{'name': 'PN 400 (VIMOVO)', 'type': 'DRUG', 'otherNames': ['PN 400'], 'description': '500 mg naproxen/20 mg esomeprazole bid', 'armGroupLabels': ['ARM 1 PN 400 (VIMOVO)']}, {'name': 'celebrex', 'type': 'DRUG', 'description': '200 mg celecoxib qd', 'armGroupLabels': ['Arm 2 (celebrex)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'sugar pill bid', 'armGroupLabels': ['Arm 3 (placebo)']}, {'name': 'Rescue Antacid', 'type': 'DRUG', 'description': 'Antacid Tablets', 'armGroupLabels': ['ARM 1 PN 400 (VIMOVO)', 'Arm 2 (celebrex)', 'Arm 3 (placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27517', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'POZEN', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Everardus Orlemans, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'POZEN'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'POZEN', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}